Total 13 Others level Quality Assurance / Control job vacancies in Dublin

Equifax is where you can power your possible. If you want to achieve your true potential, chart new paths, develop new skills, collaborate with bright minds,  and make a meaningful impact, we want to hear from you.

We are looking for a Senior Quality Engineer with extensive experience and a very good understanding of coding practices (Java preferred) who is passionate about quality and how customers experience the products tested. Looking for a candidate with a proven ability to develop Test Strategies and Plans in conjunction with App Engineering, Architecture and Prod Arch. This includes test data creation and management. The Sr. Quallity Engineer should be self driven and motivated and have a proven ability to lead and guide people (2 or 3). Looking for a candidate that has demonstrated an ability to influence and collaborate with other teams with extensive experience in automating both web and backend services in a microservice environment. The Sr. Quality Engineer should have experience working in cloud platforms (preferably GCP, certification strongly preferred) and a proven ability to analyse and report on the root cause of defects.

What you'll do:

• Be a catalyst in both the development and the testing of high priority initiatives. 
• Develop and test new products to support technology operations while maintaining exemplary standards. 
• Take an active part in all Agile (Scrum) ceremonies such as sprint planning, backlog grooming and retro's.
• Ensure end-customer needs and associated value chain to drive processes and practices to ensure flawless customer experience.
• Create test automation suite and design necessary documentation for automated processes.
• Identify and automate regression tests for future regression scenarios.
• Influence Change Management, CI/CD, tools integration.
• Modify SDLC to assure proper adherence to Equifax Engineering Handbook (including Security).
• Execute all test cases, and detect defects early.
• Pretest and validate deployment plans with steps to be taken.
• Execute post-deployment verification plans and record results.
• Execute resilience testing plan and results.
• Validate and report on application code quality and ensure it meets Equifax code standards.
• Establish and maintain common defect severity definitions across the tribe so that there is alignment between teams.
• Complete Web accessibility testing with no open violations for customer facing web interfaces (WCAG).
• Ensure application vulnerability and penetration testing is completed and any violations resolved.
• Will raise any issues with developers and product owners.
• Will shorten and amplify feedback loops to deliver products faster and with higher quality

What experience you need:

• BS or MS degree in Computer Science or Business or equivalent job experience required.
• 5+ years’ in software testing and test automation.
• 2+ years as a senior Quality Engineer, leading other Engineers.

What could set you apart:

• Active Cloud Certification strongly preferred.
• Exposure to cloud and Infrastructure as code concept.
• Expertise with cross device testing strategies and automation via device clouds.
• Experience preparing and delivering executive level presentations to businesses and technology audiences.
• Experience monitoring and developing resources.
• Excellent coding and analytical skills.
• Experience with performance engineering and profiling (e.g. Java JVM, Databases) and tools such as JMeter.
• Some exposure to Application performance monitoring tools like Datadog.
• Experience working in a TDD/BDD environment and can utilise technologies such as JUnit, Rest Assured/Karate/Selenium frameworks, API tools such as Postman.
• You understand Continuous Delivery concepts and can use tools including Jenkins/Bamboo and vulnerability tools such as Sonar, Checkmarx/Fortify, etc.

#LI-JD1

#LI-hybrid

The Perks of being a Equifax Employee?

We offer a wide range of company supported benefits including contributory pension, life cover, income protection, healthcare, enhanced maternity and sick pay, 26 days holiday and a day off for your birthday, with the ability to buy and sell and free credit checks. We also offer flexible benefits ranging from cycle to work, discounted travel options, gym membership, dining and leisure discounts, financial & savings plans, mobile discounts plus much more!

We also support personal development and have a range of learning options including our global online learning platform and allow you to bring your whole self to work supported by our Inclusion and Diversity, Wellbeing and Employee Engagement forums.

Are you ready to power your possible?  Apply today, and get started on a path toward an exciting new career at Equifax, where you can make a difference!
 

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Quality Control External Support Specialist

Your role will be in the Quality Control Department as part of an expanding and diverse team of welcoming and supportive colleagues. You will be directly involved in providing quality and analytical expertise to external customers and you will also provide support to regulatory submissions in those markets.

This is an exciting opportunity to join a world class facility, which is dedicated to bringing therapies to the market that will significantly improve patients’ lives.

Job Purpose

Support external analytical method transfer projects and new product introduction for both established and new products including mRNA programmes. You will coordinate and execute activities to ensure completion of method transfer projects to schedule.

Support regulatory activities including those related to review of analytical sections in both new and updated submissions as well as query responses.

Support Pfizer sites, board of health laboratories and OMCL/NCL’s test laboratories to enable local market testing as part of dossier pre-approval and product release requirements.

Reporting Structure

QC Lead

⇧

QC Senior Manager

⇧

QC External Support Lead

⇧

QC Specialist

About the Role / Job Responsibilities

• Management of external analytical method transfer and new product introduction projects including mRNA products to rest of world markets and new emerging markets/localisation projects.
• Liaise with customers both internal and external to support overall method transfer processes.
• Provide technical support to all new country launches.
• Technical author, review, and critique of analytical/regulatory leaflets for all new filing applications for established and new products including mRNA products.
• Address product analytical queries from global regulatory teams in support of new and updated submissions.
• Co-ordination and technical review of responses to agency questions on analytical methods.
• Support importation testing queries and support for rest of world labs via country affiliates and from packing sites.
• Support the implementation of analytical methods in Official Medicines Control Laboratories (OMCL’s) and National Control Laboratories (NCL’s) as part of product market release.  
• Technical/analytical support to Board of Health Labs and OMCL/NCL laboratories on analytical queries related to products.
• Representative/active participant on cross functional analytical and product teams.
• Representative at Change Control review boards to assess impact of all changes presented and follow up on assigned implementation activities.
• Support operations of the Quality Control testing laboratories as requested by QC management for example assay execution or data review.
• Support teams to provide QC assessments/information related to analytical test procedures/data trends/other analytical data as required.
• Support opportunities for Continuous Improvement within the team and embrace the company’s culture to own and drive any activities associated with delivering these improvements.
• Provide support to agency site inspections as required.
• Host visits to site from Board of Health Laboratories or other government agencies from ROW in support of future import testing requirements locally or as part of new product submissions.
• Implement and adhere to appropriate levels of cGMP within the team and promote safety awareness and the established culture of incident and injury free within the area.
• Perform and assist in additional duties as may be directed by QC External Support Manager / senior Manager.
• Some travel may also be required as part of this role.

About You

To be successful in this role you will require:

• B.Sc. degree in biological/chemical sciences, business, or other related technical degree or equivalent experience in regulated industry.
• Minimum of 4-6 years working experience within a QA/QC GMP environment in a pharma/ biotech company.
• Experience with technical elements of the analytical method validation and transfer process.
• Proven knowledge in analytical techniques, analytical instrumentation theory and practice.
• Proven ability to recognise problems with equipment, methods, software, procedures and resolve the issues.
• Experience working with regulatory submission processes and regulatory queries.
• Experience with Quality and Laboratory systems an advantage.
• Excellent communication, and interpersonal skills.
• Proven success in proactive project management.
• Experience in managing multiple projects to tight timelines and reporting regularly to management within the organisation.
• Proven ability to communicate problems and required resolution in a positive and proactive manner.
• Self-directed, self-motivated with a demonstrated record in project accountability.
• Demonstrated success in networking across sites/functional teams.
• Ability to work independently, as well as a member of a team in a dynamic, fast-paced environment.
• Working knowledge of six sigma, Lean Tools/management systems, QTS and GDMS.

People/Values:

• Demonstrate Company Values and Behaviors.
• Adhere to all HR Policies as appropriate.
• Recognition is actively practiced by you and across the team.
• Proactive engagement with key stakeholders.
• Best practices developed and shared with other teams /sites.
• Best practices actively sought and copied.
• Proactive & effective communication within and across teams.
• Support use of Lean tools and IMEX systems within the team to manage workload and implement continuous improvements.

Purpose   

Breakthroughs that change patients' lives... At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives.  

Digital Transformation Strategy  

One bold way we are achieving our purpose is through our company wide digital transformation strategy. We are leading the way in adopting new data, modelling and automated solutions to further digitize and accelerate drug discovery and development with the aim of enhancing health outcomes and the patient experience.  

Equal Employment Opportunity  

We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating this, in all its forms – allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees.  

Quality Assurance and Control 

 
Work Location Assignment: On Premise

Why Patients Need You

Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients.  Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.

What You Will Achieve

The role of the Quality Operations Manager is to support the Quality Lead in establishing and maintaining an appropriate and sustainable Product Quality System and Quality Culture at the Pfizer Country Office (PCO) in order to ensure compliance with Pfizer and Regulatory Authority expectations.

In addition, the QO Manager will act as delegate for the Quality Lead in the investigation and resolution of all product quality issues discovered or originating in the Pfizer Country Office (PCO) and for interacting with the relevant local stakeholders (such as Regulatory Affairs, Medical) and Pfizer Global Supply (PGS) on such issues.

The QO Manager will assist the Quality Lead with the monitoring of product quality and compliance activities at the PCO, to ensure current regulatory expectations are met, and facilitate internal and regulatory GMP/GDP inspections.

The QO Manager will also assume the role of Deputy Responsible Person on Pfizer Healthcare Ireland’s Wholesale Authorisation.

How You Will Achieve it:

1. Resolution of Product Quality Compliance Issues

Deviation Management:

• Investigate, together with appropriate local functions, deviations from Product Quality and Compliance requirements that occur within the responsibility of the country organization and agree and track preventive/corrective actions. 
• Ensure that any deviations to GxP process are assessed and fully investigated and any associated CAPA are correctly tracked.

Product Complaint handling:

• Oversee the intake and triage of complaints from the local market.
• Ensure any suspect falsified medicine is investigated and reported.

Notification to Management

• Inform PCO key stake holders and PGS QO Management of significant deviations and complaints.
• Act as delegate for the Quality Lead at Quality review team meetings and plan local actions such as communication with Regulatory Authority, local corrective/preventive actions and market actions as required.
• Participate in Rapid Response Teams (RRT) in formulating communication packages for the Regulatory Authority.

2. Quality Management System

• Assist the Quality Lead with the maintenance of the Quality Management System,
• Manage a gap analysis process for the effectiveness of Global SOPs against PCO requirements. Ensuring all gaps are appropriately risk assessed and accounted for.
• Monitor key quality performance indicators, evaluate and highlight any significant trends and identify actions.
• Conduct internal assessments to assess compliance with quality management systems and processes, and to identify improvement opportunities.  

3. Local Product Disposition

• Provide support to the team in the management of the local release of receipted products, in compliance with local procedures, prior to distribution/sale within Ireland.
• Conduct assessment of medicinal product returns that can be taken back to saleable stock and support local actions, in cooperation with logistics service provider (LSP).

4. Inspections and Internal Audit

• Support the preparation and coordination of Regulatory Authority and internal Pfizer inspections of Product Quality and Compliance (GMP/GDP) activities in Ireland.
• Work with local functions to define an appropriate action plan to address inspection/audit deficiencies.
• Track the implementation of the identified actions within agreed timeframes
• Conduct Self-Inspections/quality reviews of local functions and processes to ensure compliance with GMP/GDP activities.

5. Logistic Service Provider Oversight

• Assist with the quality oversight of the Logistics Service Provider (LSP), which includes but is not limited to:
• Deviation Management: evaluate the impact of all significant deviations affecting product quality, generated at the LSP and agree corrective actions.
• Quality System Support: visit the LSP to assess quality systems, review quality performance and agree action plans to ensure continuous improvement.
• Support the Quality Lead with the facilitation of the Pfizer corporate audit process at the LSP and assist in defining appropriate action plans for improvement and follow-up.

6. Business Support and Development

• Act as delegate for the Quality Lead as required in PCO critical business processes, e.g. LSP Management Reviews.
• Participate in business initiatives as required, giving advice and direction on effects to quality and compliance.

Qualifications

Must-Have:

• Life sciences degree.
• Extensive experience working for a Pharmaceutical Company in Quality Assurance (QA)/Quality Control (QC).
• In-depth knowledge and understanding of Quality systems, processes, audit and inspection.
• Excellent communication and interpersonal skills.
• Attention to detail.
• Continuous improvement orientation.

Nice-to-Have:

• Good in-depth knowledge and understanding of Irish and EU legislation, guidelines and procedures relating to GDP
• Eligible as a Deputy Responsible Person.
• Strong negotiation and effective communication skills.
• Excellent system skills – Word and Excel essential, experience with electronic documentation control systems.

Make a difference today! All suitable candidates should apply through the link with CV provided. We are looking forward to hearing from you!

In order to be considered for this position you need to be legally eligible to work in the EU.

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Due to the high volume of applications we will be contacting successful candidates only.

Deloitte is the biggest professional services Firm in the world making an impact is more than just what we do: it’s why we’re here. We’re driven to create positive progress for our clients, community, people, and the planet. This sense of purpose inspires us to work to the highest standards, to tackle the challenges that matter. 

Audit & Assurance is one of our biggest service lines and the driving engine of Deloitte Ireland. We provide services that go beyond expectations to deliver insight and confidence for our leading international and local clients.   

Our Audit and Assurance teams are a key part of the financial reporting ecosystem. Deloitte is constantly evolving its audit and assurance processes providing value and insights. We leverage cutting-edge technology in combination with our global network of professionals applying diverse skills and experiences to make an impact that matters to our clients.

We are delighted to announce that the Deloitte Ireland Return to Work programme is open for applications. Designed to support those who have taken a career break of 18+ months, as of September 2024, (including career breaks of 10+ years) and wish to return to the workforce.

The programme is offered in hybrid working in line with our Deloitte Works policy. Depending on the role, various flexible working options may also be available during and after the programme.

All our returners receive internal coaching and mentoring, support from previous Deloitte returners and will be assigned a buddy, their point of contact for all day-to-day queries and support. Participants also avail of group coaching with Career Returners, our expert returner coaching partner, to help them successfully transition back to work.

The programme offers a paid 6-month placement in Deloitte. The roles are at a professional level and towards the end of the programme there will be potential to convert to permanent roles with Deloitte.

We welcome applications who are particularly interested in the Sustainability area of our Audit & Assurance business.

About the role:

• Leading sustainability assurance engagements across all industries, acting in the capacity of ‘Senior in charge’, taking ownership for all aspects of engagement delivery working with the manager on scoping, programme and team selection through to delivery, quality management and budgetary control
• Delivering an innovative approach to our sustainability assurance service offering
• Drive client business development activities for sustainability, supporting our go to market activities, demonstrating ability to generate leads and expand our opportunities in this area

About you:

• Qualified accountant
• Desire to work as part of high performing team covering a range of sustainability matters, in a dynamic, challenging environment
• Strong academics and relevant qualifications (e.g., assurance experience, qualified accountant, sustainable development, environmental sustainability etc.)

If you believe that you don’t meet all the criteria above but would have a strong skill set and experience, we encourage you to apply to the programme, but bear in mind that you must have the right to work in Ireland to do so.

What is the recruitment process?

• Stage 1: Make sure to complete your application on Workday by 5pm on 19 April
• Stage 2: Interviews will take place in May 2024, this is a two-stage interview process
• Stage 3: The Deloitte Return to Work Programme will start on 2 September 2024. All successful candidates will start the programme on this date with a group of returners

Please send any questions you may have to our dedicated Return to Work mailbox; returntowork1@deloitte.ie.

If you believe that you meet most of the criteria above, we advise you to apply. Deloitte is an equal opportunities employer and will ensure any reasonable accommodations are implemented as part of the recruitment and selection process.​

What we offer

Your reward at Deloitte is competitive, supports our purpose and enables our people to never stop growing. Your reward at Deloitte is not just your salary, we believe in investing in our people's personal and professional development and empowering their work-life balance. Our ambition is to achieve gender equality and enable continuous growth. We offer supports and benefits that suit you, wherever you are in life, including health and well-being, pension, savings, training, coaching and enhanced leave options among others.

Keep on being you. Bring your full, absolute self to work, every day. Explore, question and collaborate. Stretch your thinking, while building a career that inspires and energises you. And, whatever motivates you, keep growing both professionally and personally – because when you make an impact that matters, we do too.

Deloitte is the biggest professional services Firm in the world making an impact is more than just what we do: it’s why we’re here. We’re driven to create positive progress for our clients, community, people, and the planet. This sense of purpose inspires us to work to the highest standards, to tackle the challenges that matter. 

Audit & Assurance is one of our biggest service lines and the driving engine of Deloitte Ireland. We provide services that go beyond expectations to deliver insight and confidence for our leading international and local clients.   

Our Audit and Assurance teams are a key part of the financial reporting ecosystem. Deloitte is constantly evolving its audit and assurance processes providing value and insights. We leverage cutting-edge technology in combination with our global network of professionals applying diverse skills and experiences to make an impact that matters to our clients.

We are delighted to announce that the Deloitte Ireland Return to Work programme is open for applications. Designed to support those who have taken a career break of 18+ months, as of September 2024, (including career breaks of 10+ years) and wish to return to the workforce.

The programme is offered in hybrid working in line with our Deloitte Works policy. Depending on the role, various flexible working options may also be available during and after the programme.

All our returners receive internal coaching and mentoring, support from previous Deloitte returners and will be assigned a buddy, their point of contact for all day-to-day queries and support. Participants also avail of group coaching with Career Returners, our expert returner coaching partner, to help them successfully transition back to work.

The programme offers a paid 6-month placement in Deloitte. The roles are at a professional level and towards the end of the programme there will be potential to convert to permanent roles with Deloitte.

We welcome applications for any of the following areas within in our Audit & Assurance business:

• Core Audit: Working on key client engagements providing accounting and auditing services

• Assurance services: Working in one of our Assurance teams (e.g., Sustainability, Accounting Operations, US GAAP (Generally Accepted Accounting Principles)) providing specialist advisory services to our clients

About you:

• Qualified accountant

• Previous experience on audit engagements and delivering to tight deadlines

• Ability to develop effective relationships with clients and with colleagues

If you believe that you don’t meet all the criteria above but would have a strong skill set and experience, we encourage you to apply to the programme, but bear in mind that you must have the right to work in Ireland to do so.

What is the recruitment process?

• Stage 1: Make sure to complete your application on Workday by 5pm on 19 April

• Stage 2: Interviews will take place in May 2024, this is a two-stage interview process

• Stage 3: The Deloitte Return to Work Programme will start on 2 September 2024. All successful candidates will start the programme on this date with a group of returners

Please send any questions you may have to our dedicated Return to Work mailbox; returntowork1@deloitte.ie.

If you believe that you meet most of the criteria above, we advise you to apply. Deloitte is an equal opportunities employer and will ensure any reasonable accommodations are implemented as part of the recruitment and selection process.​

What we offer

Your reward at Deloitte is competitive, supports our purpose and enables our people to never stop growing. Your reward at Deloitte is not just your salary, we believe in investing in our people's personal and professional development and empowering their work-life balance. Our ambition is to achieve gender equality and enable continuous growth. We offer supports and benefits that suit you, wherever you are in life, including health and well-being, pension, savings, training, coaching and enhanced leave options among others.

Keep on being you. Bring your full, absolute self to work, every day. Explore, question and collaborate. Stretch your thinking, while building a career that inspires and energises you. And, whatever motivates you, keep growing both professionally and personally – because when you make an impact that matters, we do too.

Deloitte is the biggest professional services Firm in the world making an impact is more than just what we do: it’s why we’re here. We’re driven to create positive progress for our clients, community, people, and the planet. This sense of purpose inspires us to work to the highest standards, to tackle the challenges that matter. 

Audit & Assurance is one of our biggest service lines and the driving engine of Deloitte Ireland. We provide services that go beyond expectations to deliver insight and confidence for our leading international and local clients.   

Our Audit and Assurance teams are a key part of the financial reporting ecosystem. Deloitte is constantly evolving its audit and assurance processes providing value and insights. We leverage cutting-edge technology in combination with our global network of professionals applying diverse skills and experiences to make an impact that matters to our clients.

About the role:
As a Senior Manager, the successful applicant will have responsibility for the following:
 

• Lead the sustainability reporting and assurance team.
• Drive client business development activities for sustainability, supporting our go to market activities, demonstrating ability to generate leads and expand our opportunities in this area
• Leading sustainability assurance engagements across all industries, acting in the capacity of ‘engagement Senior Manager, taking ownership for all aspects of engagement delivery from scoping, programme and team selection through to delivery, quality management and budgetary control
• Delivering an innovative approach to our sustainability assurance service offering
• Leveraging your in depth knowledge of the sustainability landscape to enable you to act in the capacity of ‘trusted advisor’ for client stakeholders.
• Developing thought leadership and market eminence related to sustainability

About you:
 

• Must have external audit experience and accredited to be an auditor (Essential)
• Understanding all spectrums of sustainability (i.e. Environmental, Social and Governance)
• Understanding of sustainability reporting frameworks e.g. TCFD, GRI, UN SDG, UN PRI, CSRD/NFRD. SFDR, EU Taxonomy etc.
• Demonstrate abilities to develop assurance frameworks using ISAE 3000 standard.
• Experience assessing the impact of climate change risks
• Outstanding academics and relevant qualifications (e.g. sustainable development, qualified accountant, environmental sustainability etc.)

If you believe that you meet most of the criteria above, we advise you to apply. Deloitte is an equal opportunities employer and will ensure any reasonable accommodations are implemented as part of the recruitment and selection process.​

What we offer

Your reward at Deloitte is competitive, supports our purpose and enables our people to never stop growing. Your reward at Deloitte is not just your salary, we believe in investing in our people's personal and professional development and empowering their work-life balance. Our ambition is to achieve gender equality and enable continuous growth. We offer supports and benefits that suit you, wherever you are in life, including health and well-being, pension, savings, training, coaching and enhanced leave options among others.

Keep on being you. Bring your full, absolute self to work, every day. Explore, question and collaborate. Stretch your thinking, while building a career that inspires and energises you. And, whatever motivates you, keep growing both professionally and personally – because when you make an impact that matters, we do too.

Manager, Ethics & Compliance Central Europe

At Cardinal Health, we aim to be a trusted partner, offering a broad range of innovative solutions that help our customers provide cost-efficient, more effective healthcare. Join our team of 50,000 humble partners striving each day to make healthcare more efficient, providers more effective, and patients as healthy as possible.

We are currently looking to recruit a Manager, Ethics and Compliance, Central Europe (French Speaking). Based in Ireland, Spain or Italy and reporting to the Head of International Compliance, you will be responsible for, but not limited to, the following. Responsible for managing and providing guidance on the compliance tasks for some of the Cardinal Health European Direct Markets (France, UK, Ireland, BeNeLux, Switzerland, Italy, Germany) - and in general for activities which will involve and be organized for the EMEA region.

Essential Functions and Responsibilities

This includes the following:

• Provide compliance advice to leaders, Sales & Marketing, Medical Affairs, and other functions building a solid and trusted relationship

• Define annual awareness and communication plans

• Develop and implement compliance policies and procedures

• Deliver compliance training to new employees and conduct periodical or ad-hoc refresh training

• Review and approving interactions with healthcare professionals (HCP) and Healthcare Organizations (HCO) such as commercial sponsorship, fee for service with HCP, educational grants, fellowships, Initiated Investigating Studies, etc.

• Review and approve Third-Party Intermediaries (TPI) (mainly distributors and higher risk vendors) in the area of competency

• Perform and/ or support during monitoring on interactions with HCP and HCO as well as other transfer of value to HCP and HCO

• Support during monitoring on TPI, etc.

• Work together and constantly align with other corporate and International Ethics and Compliance colleagues and closely with the Head of International Compliance in order to enhance the Corporate and the International Compliance Program for International Medical Products and Distributions (IMPD) region

• Work in cross functional projects providing compliance advice and ensuring that all mitigating controls are in place

• Support the Interaction with Customers Center of Excellence in collecting, reviewing and publishing the transparency reports required in the countries of responsibilities

• Support the International Compliance Investigation Lead during compliance investigation in conducting interviewing and reviewing documentation

• Collect, prepare and analyze interactions with Customers data using company tools and any other advanced solutions and tools in order to create dashboard and provide reports to be used during presentations to leaders and for enhancing the compliance programs helping in assessing and focusing on specific risk areas

• Support Head of International Compliance in preparing slide deck and presentations for leaders

• Maintain current knowledge of regulations and authority expectations and monitor changes in all applicable regional and local laws, regulations and guidelines, issuing appropriate recommendations.

Qualifications and Experience

• Bachelors degree in Business, Finance, Legal or equivalent

• 5 years of relevant experience in Compliance, Internal audit

• Languages: fluency in English and French, both oral and written is a must, other language knowledge is a plus

• Knowledge of data processing and analysis

• knowledge of conducting audits as well as investigations

• Knowledge of the pharmaceutical or medical device industry and healthcare sector

• Experience of working with Third Party Intermediaries, mainly distributors

• In depths experience to work and operate in a multi-cultural international setting

• Experience working for US-based company.

The Company

Headquartered in Dublin, Ohio, Cardinal Health (NYSE: CAH) is a health care services company that improves the cost-effectiveness of healthcare. As the business behind healthcare, Cardinal Health helps pharmacies, hospitals and ambulatory care sites focus on patient care while reducing costs, improving efficiency and quality, and increasing profitability. Cardinal Health is an essential link in the healthcare supply chain, providing pharmaceuticals and medical products to more than 100,000 locations each day and is also the industry-leading direct-to-home medical supplies distributor. The company is a leading manufacturer of medical and surgical products, including gloves, surgical apparel and fluid management products. Ranked among the top 20 on the Fortune 500, Cardinal Health employs more than 50,000 people worldwide.

#LI-Remote

Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply.

Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.

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Career Category

Job Description

Specialist Quality Assurance

The Quality Assurance (QA) Specialist will be an active member of the ADL QA team.  The QA Specialist will be assigned to the Incoming Quality Assurance (IQA) functional area, which is responsible for the inspection and release of incoming primary and secondary packaging components and sampling of raw materials. The QA Specialist will report to a QA Senior Manager.

In addition to routine Quality Assurance duties, QA Specialists may be assigned specific oversight and responsibilities for key quality systems or processes and may also serve as a primary quality partner/point of contact for functional areas within ADL, including Supply Chain, Information Systems, Manufacturing, Process Development, Validation, Engineering and Quality Control.

Incoming Quality Assurance Specialist Key Responsibilities

• Act as Quality point of contact for incoming inspection and sampling processes, providing advice to ensure all activities meet internal and regulatory expectations.
• Oversight of ADL and external Warehouse activities.
• Manage the introduction of new techniques and equipment to IQA, including method transfers, and validations
• Assume ownership and/or oversight of change control and Deviation/CAPA records; ensuring the scope of record is clear and implementation activities are robust and timely.
• Write, review and approve Standard Operating Procedures in accordance with Amgen Policies.
• Participate in product complaint investigations, as required.
• Provide training and advice to staff in relation to testing of components.
• Actively participate in audits and their preparation.
• Evaluate practices for compliance and operational excellence improvement on a continuous basis.
• Perform all activities in compliance with Amgen safety standards and SOPs
• Ensure all GMP compliance training is up to date before performing GMP activities and participate in training of new colleagues
• Perform all tasks with due care and attention and in accordance with Good Manufacturing Practices and Amgen requirements, policies, and procedures.

In line with business requirements, these responsibilities may expand or otherwise include additional areas of responsibility which are not described in this specification but are associated with the role

The knowledge and skills necessary to perform the duties of the QA Specialist are typically acquired through the following combination of education, experience, and knowledge.

Basic Qualifications:

University degree - Engineering or Science related discipline preferred.

Relevant experience (8+ years) working in the pharmaceutical or biotechnology industry or other combination of experience and educational background that may otherwise satisfy the requirements of the role.

Preferred Qualifications:

Excellent written and verbal communication skills

Experience working with dynamic cross-functional teams and proven abilities in decision making and influencing

Strong organizational skills, including ability to follow assignments through to completion

Demonstrated ability in problem solving and experience in managing Root Cause Analysis / Deviation investigations

Detailed Knowledge of applicable Regulatory requirements. Experience with Regulatory inspections.

Summary:

This is a hands-on technical role requiring current experience working with large scale, cross-functional automation frameworks providing well-balanced coverage across UI, back-end integration and database levels.

The candidate should be a sharp, experienced senior level automation engineer  with strong problem-solving skills and a solid software testing foundation. This role requires a talented, detail oriented, enthusiastic individual who is passionate about quality with the ability to grasp tough issues quickly and deliver well engineered, high quality solutions.

We are looking for a strong Java software engineer to build out the next generation of our software test automation infrastructure. The candidate will be responsible for designing, developing, delivering and supporting the software infrastructure that enables automated product validation to the rest of the development community at Charles River Development.

The role will work with the Automation Infrastructure Team and the Product Scrum Teams  to implement cutting edge complex quality engineering automation frameworks, tools and other solutions for software development and deployment initiatives to ensure the software meets quality expectations.

The candidate will be well versed, hands-on with testing methodologies, automation techniques, knowledge of multiple tools in functional, non-functional test automation, latest trends and best practices in the testing industry and for integration with DevOps and DevOpsSec. The individual will have a solid understanding of test automation approaches (keyword-driven, Data-driven, TDD, BDD) and technology stacks (Java, Python, JavaScript, Groovy etc.). The individual will work to integrate test automation into CI/CD process and instrument full SDLC automation, including cloud testing execution and reporting tools such as Jira.
 

Proven experience in leading test automation and process automation with cutting edge tools for Web, Desktop, DB and Web-service testing (Selenium, Ready API, etc.) is desired. Strong analytical and problem-solving skills with the ability to work in a fast-paced environment will be essential.

Experience in in identifying test data management needs and implementing them is a must.

Financial services industry experience is preferred.

The role will require an individual who can mentor QA team members to implement and scale automation.

Responsibilities:

• Develop C# and Jave code for the management of automation infrastructure.
• Develop API’s facilitating the creation of rich automation test suites by the product development teams.
• Debug and correct problems in the automation infrastructure code.
• Implement performance profiling of code and propose solutions to address defects.
• Design test environments for cloud native applications.
• Analyze systems and procedures and implement necessary improvements.
• Engage with teams/projects to assess their maturity level and recommend and/or assist in implementing test automation for the given functional area.
• Create comprehensive test automation scripts from business requirements and functional specifications documents for product features of moderate complexity.
• Execute automated functional, integration, regression, and performance tests.
• Maintain automated script libraries for functional, integration, regression, and performance testing.
• Interpret results of automation tests and document software defects in issue tracking system; proactively communicate issues with developers and other project team members.
• Provide testing leadership by identifying opportunities for improvement in the Scrum team’s QA automation methodology.
• Keep abreast of automation testing technologies and best practices with an eye to evolving automation frameworks and testing methodologies.
• Assist in driving mature test automation capabilities, such as BDD/ATDD capabilities that allow teams to shift testing and test automation as far left as possible.
• Improve the Testing/automation architecture by continuously reducing the testing cycle time enabling the CI\CD models by working closely with various teams
• Assist in developing the required testing automation dashboards to monitor application KPIs, utilizing relevant technology for effective quality assurance monitoring
• Manage all test environments, test devices and OS versions required for testing
• Define test data for robust automated testing and implement a process to maintain and expand that “Gold” copy of the data for QA.
   

Qualifications:

Education:

B.S. degree (or foreign education equivalent) in Computer Science, Engineering, Mathematics, and Physics or other technical course of study or Business with an MIS background. MS degree strongly preferred.

Experience:

• 8+ years of experience with C# and Java development.
• Strong programming skills to be able to develop automation infrastructure effectively.
• Experience with PowerShell and batch scripts.
• Experience with virtualization technologies such as VMware, Docker, etc.
• At least 5 years of experience with various automation tools.
• Experience with Silk4Net is a plus.
• Experience with JavaScript-based technologies and best practices.
• At least 3 years of experience with Snowflake and SQL Server database.
• Knowledge of Agile/Scrum Development processes, QA processes and standards.
• Ability to conduct administration in Windows and Linux environments.
• Ability to multitask ongoing project tasks while supporting a variety of incoming questions from the development community.
• Ability to provide guidance on how to troubleshoot issues.
• Experience in the financial industry a plus.
• Hands-on experience in developing and maintaining automated test suites.
• 2+ years of experience in Micro services, Web services testing using SOAP and REST based service & XML, JSON.
• Experience with CI/CD tools such as Jenkins, GIT and other relevant tools.
• Exposure to testing tools such as Selenium Webdriver, Gradle, Jenkins.
• Familiarity with Teamcity, Git, Confluence, JIRA, Docker, ELK stack.
• Strong experience with database testing (Oracle, SQL/NoSQL).
• Experience working with mixed onshore/offshore teams.
• Experience in cloud application projects preferably Azure.
• Superior communication and organizational skills.
• Strong ability to work as part of a team, demonstrate initiative and solve problems independently.

Supervisory Responsibility:

☒ Individual Contributor                    ☐ Team Lead                     ☐ Manager of Managers

Travel:

May be required on a limited basis.

Summary:

The candidate should be a sharp automation engineer with strong problem-solving skills and a solid software testing foundation. This role requires a talented, detail oriented, enthusiastic individual who is passionate about quality with the ability to grasp tough issues quickly and deliver well engineered, high quality solutions.

We are looking for a strong C# software engineer to build out the next generation of our software test automation infrastructure as part of our Quality Assurance Infrastructure team. The candidate will be responsible for developing, delivering and supporting the software infrastructure that enables automated product validation. This position provides services for planning and the execution of central automated regression runs for all product departments. In addition, this candidate is responsible for maintaining and expanding the labs which host both automated and manual testing as well as conducting staging and certification of the product media during the ship-stage of a release.

This position will work with the QA Automation Infrastructure Team Lead to implement cutting edge complex quality engineering automation frameworks, tools and other solutions for software development and deployment initiatives to ensure the software meets quality expectations.

The candidate will be familiar with testing methodologies, automation techniques and knowledge in multiple tools for functional, non-functional test automation. The individual will have a good understanding of test automation approaches (keyword-driven, Data-driven, TDD, BDD) and technology stacks (Java, Python, JavaScript, Groovy etc.). The individual will work to integrate test automation into CI/CD process and instrument full SDLC automation, like cloud testing execution and reporting tools such as Jira
 

Experience in test automation and process automation with cutting edge tools for Web, Desktop, DB and Web-service testing (Selenium, Ready API, etc.) is preferred. Strong analytical and problem-solving skills with the ability to work in a fast-paced environment will be essential.

Financial services industry experience is a plus.

Responsibilities:

• Provide automation support and guidance to Dev Teams.
• Script development with Java, C#, SQL and shell scripting languages
• Implement and execute automation test scripts against web, native/desktop applications, APIs and batch applications

Qualifications:

Education:

B.S. degree (or foreign education equivalent) in Computer Science, Engineering, Mathematics, and Physics or other technical course of study or Business with an MIS background. MS degree strongly preferred.

Experience:

• Experience with C# development.
• Strong programming skills to develop automation infrastructure effectively.
• Experience with ASP.NET web development.
• Experience with Java, PowerShell and batch scripts.
• Experience with virtualization technologies such as VMware, Docker, etc.
• 3+ years of experience with various automation tools.
• Experience with Silk4Net is a plus.
• Experience with JavaScript-based technologies and best practices is a plus.
• Experience with Linux and Oracle and SQL Server database is a plus.
• Knowledge of Agile/Scrum Development processes, QA processes and standards.
• Ability to conduct administration in Windows and Linux environments.
• Excellent communication skills.
• Ability to multitask ongoing project tasks while supporting a variety of incoming questions from the development community.
• Ability to provide guidance on how to troubleshoot issues.
• Familiarity with CI/CD tools such as Jenkins and GIT and other relevant tools.
• Exposure to testing tools such as Selenium Webdriver, Gradle, Jenkins.
• Familiarity with Teamcity, Git, Confluence, JIRA, Docker, ELK stack.
• Experience working in automated test and continuous deployment environments.
• Experience working with mixed onshore/offshore teams.
• Experience in cloud application projects preferable Azure.
• Superior communication and organizational skills.
• Strong ability to work as part of a team, demonstrate initiative and solve problems independently.

Supervisory Responsibility:

☒ Individual Contributor                    ☐ Team Lead                     ☐ Manager of Managers

Travel:

• May be required on a limited basis.

About Charles River Development

Charles River Investment management System in an platform that provides many Front-Office functions including Portfolio Management, Order Management and Execution, Compliance, Performance & Attribution, Modelling, Scenario Analysis, and Wealth Management.

We are part of the State Street Bank. State Street is one of the largest custodian banks, asset managers and asset intelligence companies in the world. From technology to product innovation, we’re making our mark in the financial services industry. For more than two centuries, we’ve been helping our clients safeguard and steward the investments of millions of people. We provide investment servicing, data & analytics, investment research & trading and investment management to institutional clients.

Work, Live and Grow. We make all efforts to create a great work environment. Our benefits packages are competitive and comprehensive. Details vary in location, but you may expect generous medical care, insurance and savings plans among other perks. You’ll have access to flexible Work Program to help you match your needs. And our wealth of development programs and educational support will help you reach your full potential.

Inclusion, Diversity and Social Responsibility. We truly believe our employees’ diverse backgrounds, experiences and perspective are a powerful contributor to creating an inclusive environment where everyone can thrive and reach their maximum potential while adding value to both our organization and our clients. We warmly welcome candidates of diverse origin, background, ability, age, sexual orientation, gender identity and personality. Another fundamental value at State Street is active engagement with our communities around the world, both as a partner and a leader. You will have tools to help balance your professional and personal life, paid volunteer days, matching gift programs and access to employee networks that help you stay connected to what matters to you.

State Street is an equal opportunity and affirmative action employer. Discover more at StateStreet.com/careers

At KONE, we are focused on creating an innovative and collaborative working culture where we value the contribution of each individual. Employee engagement is a key focus area for us and we encourage participation and the sharing of information and ideas. Sustainability is an integral part of our culture and the daily practice. We follow ethical business practices and we seek to develop a culture of working together where co-workers trust and respect each other and good performance is recognized. In being a great place to work, we are proud to offer a range of experiences and opportunities that will help you to achieve your career and personal goals and enable you to live a healthy and balanced life.

Read more on www.kone.com/careers

Are you ready to take your career to the next level as a Contract Compliance Specialist at ZEISS in Dublin, CA? Join a vibrant corporate culture that values work life balance. Enjoy the flexibility of a hybrid schedule and the opportunity to learn new skills. No contract experience required. You must have a CA State Board of Designated Representative license. PharmD preferred.

The Contract Compliance Specialist acts as a primary contact for all communications, customer care and inquiries related to customer sales contracts. This is a collaborative position with the many partners within ZEISS including but not be limited to order administration, finance, sales, legal, logistics, accounts receivables, and other ZEISS entities. The Contract Compliance Specialist  reviews  agreements and monitors compliance to the terms and conditions.

As a CA State Board of Pharmacy licensed Designated Representative, the individual will also assist management in all aspects of purchasing, storage, distribution, and inventory management of prescription medical devices.

Requirements:

·         Currently licensed as a CA State Board of Pharmacy Designated Representative or able to meet all requirements to obtain the Designated Representative License in the State of CA and an equivalent role in other states, as applicable.

·         A minimum of three years of paid work experience, with at least one year of paid work experience in the past three years, related to the distribution or dispensing of dangerous drugs or dangerous devices in a licensed pharmacy, drug wholesaler, drug distributor, or drug manufacturer.

·         Must successfully complete a training program pursuant to Business and Professions Code section 4053

·         Fingerprints are required to be submitted with the application using Live Scan.

·         Collaborative communication skills.

·         Customer service skills that will support successful response to common inquiries or complaints from customers.

·         Ability to respond to regulatory inquiries.

·         Excellent written and verbal communication skills are necessary.

·         Self-motivated, ability to work with minimal supervision.

·         Must work well in a team environment.

·         College degree or equivalent preferred

The hourly pay range for this position is $56.00 -$65.00.

The pay offered for this role may be influenced by factors such as job location, scope of role, qualifications, education, experience, & complexity/specialization/scarcity of talent.

This position is eligible for a performance bonus.  ZEISS also offers robust benefits, including medical plans, retirement savings plan and paid time off.

Your ZEISS Recruiting Team: