Total 54 Senior Executive level Quality Assurance / Control job vacancies in Remote New York

About the Role:

This position has responsibilities for the deployment and standardization of key Quality Assurance activities including assurance of product quality, quality planning process, and maintenance of Quality Management System performance. This role will carry out responsibilities in strict adherence to regulatory requirements and applicable standards relevant to medical device, and always act with focus on quality objectives within the organization.

Roles and responsibilities:

• Functional lead for implementation, managing operational effectiveness of Complaint Handling process, trending activities, and analysis of data associated with defined KPIs.
• Responsible for monitoring and implementation escalation process and resolution for late medical device reports caused by late entries by local intake team.
• Analyze and recommend complaints received are reportable within the market, ensure adverse events reported to Authority if needed, with special attention to managing complaint-adverse event with close follow up with manufacturer and/or reporter.
• Execute, coordinate and feedback Field Corrective Action/Recalls with the countries, maintain tracking to monitor field actions in the region to ensure effective resolution or closure. Report Field Corrective Action to Authority if needed.
• Support audit readiness, conduct and prepare for regulatory/external audits as well as internal quality audits to ensure timely execution according to defined schedule.
• Participate of Nonconformity, Corrective and Preventive Actions, Documentations, Supplier Quality across the organization.
• Develop/update procedures for quality system processes to ensure alignment with Olympus global procedures as well as coordinate with other departments that effect Quality Systems.
• Provide training and support to employees concerning quality systems, policies, procedures, and core processes etc.
• Support global and local quality improvement initiatives and transformative projects.
• Execute other tasks and projects, as assigned by Manager.

About Olympus:

Our purpose at Olympus is to make peoples’ lives healthier, safer and more fulfilling. We do this through innovation. As a technology pioneer, we design and deliver solutions across our Medical division that make a positive contribution to society.

Our products are used to capture the medical and diagnostic images of our world, from the microscopic to the endoscopic. They are instrumental in furthering research, and for travelling inside the human body to help diagnose, treat and prevent illness.

Our commitment to customers and our social responsibility is the cornerstone of everything we do.

Why work at Olympus?

At Olympus, we are dedicated to fostering a high-performing culture, a collaborative environment, and enabling everyone to shine. Our common values of Patient Focus, Integrity, Innovation, Impact and Empathy, form the foundation of our culture and guide our behaviour, where our people feel like they are making a difference every single day.

Not only will you benefit from a meaningful, rewarding and challenging career, you will have access to a range of benefits:

• A competitive salary package including AWS and Variable Bonus
• Hybrid home office work arrangements
• 18 days of annual leave in your first year
• Health and Wellbeing initiatives (Annual Medical Checkups, Flu Vaccinations, Dental benefits, and Employee Assistance Programs)

What we are looking for:

• Bachelor’s degree in related field of engineering, science, or equivalent discipline.
• At least 5 years of experience working in similar position of responsibility in the medical device quality field
• Prior experience in managing quality management system in a medical device environment and quality assurance/regulatory compliance
• Must have knowledge to perform quality audit, certified auditor in ISO13485 or GDPMDS will be a plus.
• Strong knowledge of quality system requirements and medical device regulatory framework
• Meticulous and strong attention to details
• Excellent verbal and written communication skills
• Good problem solving and ability to drive change within organization
• Ability to succeed in a fast-paced, matrixed environment with speed, accuracy and adaptable to meet business need
• Positive attitude and able to work well as team player

Apply Now:

To submit your interest in this opportunity, select “Apply for this job”.

In the meantime, follow us on:

• LinkedIn - Olympus APAC
• Company website - www.olympus.com.sg

RESPONSIBILITIES

• The role involves planning, coordinating, and implementing standards development projects under the national standardization programme administered by Enterprise Singapore.
• Provide secretariat support to the Technical Committees and Working Groups. This includes preparation of agendas, meeting minutes, report compilation, drafting of standards, etc.
• Engage and coordinate with the industry, academia, and government organizations to facilitate the development, promotion, and review of Singapore Standards and Technical References.
• Organizing key standard launches events and other outreach events.
• Collaborate with key stakeholders to identify, develop, and launch new standards. This includes conducting consultations and ensuring that standards are aligned with industry needs.
• Assist in the industry and technical research for the development of new/review of standards. Conduct verification studies to identify users of the standards.
• Handle inquiries regarding standards in your area of responsibility, ensuring prompt and accurate responses to stakeholders.

Requirements

• Minimum Diploma qualification/ Fresh gradustes are welcome to apply
• Preferably with at least three (3) years of relevant work experience in safety or manufacturing related field
• Preferably with secretariat experience
• Min. 3 years of experience in quality, safety or manufacturing industry is advantageous
• Results-oriented and able to manage and execute projects in a team and independently.
• Possess good interpersonal skills and work well with various stakeholders
• Good writing and communication skills.
• Proficiency in Microsoft Word, Excel, PowerPoint, and other productivity tools

About Us:

We are the independent expert in assurance and risk management. Driven by our purpose, to safeguard life, property, and the environment, we empower our customers and their stakeholders with facts and reliable insights so that critical decisions can be made with confidence.

As a trusted voice for many of the world’s most successful organizations, we use our knowledge to advance safety and performance, set industry benchmarks, and inspire and invent solutions to tackle global transformations.

About SCPA

We help our customers respond to the increased demand for trust and transparency around products, assets, supply chains, and ecosystems, driving the transformation of the assurance industry. Whether certifying products, sharing claims or optimizing and decarbonizing supply chains, DNV helps companies manage risks and realize their long-term strategic goals, improving ESG performance and generating lasting, sustainable results. Drawing on our wide technical and industry expertise, we work with companies worldwide to bridge trust gaps among consumers, producers and suppliers.

We are looking for a Senior assessor to drive the growth of our Product Assurance business. In this role you will be responsible for assessing, inspecting and testing equipment, components and systems to customer or project specifications, and international regulations or standards like PED, CPR (steel), MD, EN 1090, ISO 3834, Welding standards, etc. In this position you will have a chance to interact with customers both external and internal, and actively participate in the section's effort towards efficiency and digitalization.

About the Role:

Responsibilities include:

• Proactive selling of our services across all domains of the business in South East Asia (SEA)
• Manage, perform, and deliver product certification and inspection activities
• Assist in preparation of customer proposals
• Provide technical guidance to customers and scoping the project with customers
• Project planning
• Complete end to end execution of the project in a timely manner with high quality.

About You:

• Graduate in Mechanical / Metallurgy engineering with 10+ years of experience in manufacturing industry.
• Qualified ISO9001 LA and IWE / IWT essential
• Experience of working with Certification or Notified Body of International Repute desirable.
• Sound Marketing Intelligence in the Inspection and Product Certification domain.
• Qualification as per PED /CPR/ ISO 3834 desirable.
• Qualified Level II for various NDE techniques.
• Sound knowledge of ASME, ASTM, EN and other related standards
• Familiar with manufacturing processes and knowledge of stage wise and final inspection of fabrication equipment, structural component, pipes, tubes, casting, forging and various mechanical component.
• Prior experience in executing small to large third party Inspections of Infrastructure, Mechanical, Electrical & Instrumentation, Civil, projects stretched over periods / months, successfully.
• Prior experience in leading Project kick-off meets, project document reviews, ITP/ QA Plan approvals, Construction procedure approvals, document MOMs, others as appropriate.
• ISO 17020/ ISO 9001 and related management systems exposure desirable. Preferably a QMS Auditor enabling vendor audits/ assessments.
• Safety conscious and enforce safe work practices.
• Good written and communication skills
• Able to work independently and in a team with good initiative
• Ability to interact and cooperate across other cultures.

Skills include:

• Sound Technical Knowledge
• Problem solving approach.
• Customer centric and managing a good customer relationship.
• Timely delivery of projects with high quality standard.

What we Offer:

• Flexible work arrangements for better work-life balance.
• Guaranteed Annual Wage Supplement.
• Generous Paid Leaves (Annual, Compassionate, Marriage, Maternity, Paternity & shared parental leave, Adoption leave, Childcare & Extended Childcare Leave, Examination leaves, National Service (NS) leave, medical leave, Prolonged Illness leave).
• Medical benefits (Clinical treatment, Emergency Medical Services, Specialist Consultation, Paediatrician Consultation, Inoculations (Hepatitis, H1N1 & Flu), Dental Treatment, Annual Medical Examination, Hospitalization & Surgical Benefits).
• Maternity Benefits.
• Pension and Insurance Policies (Central Provident Fund, Group Term Life Assurance, Group Personal Accident Insurance, Travel Insurance, Work Injury Compensation Insurance).
• Training and Development Assistance (Training Sponsorship, On-The-Job Training, Training Programme).
• Additional Benefits (Long Service Awards, Professional Membership, Gym Subsidy, Mobile Phone Reimbursement).
• Company bonus/Profit share.

*Benefits may vary based on position, tenure/contract/grade level*

DNV is an Equal Opportunity Employer and gives consideration for employment to qualified applicants without regard to gender, religion, race, national or ethnic origin, cultural background, social group, disability, sexual orientation, gender identity, marital status, age or political opinion. Diversity is fundamental to our culture and we invite you to be part of this diversity.

Responsibilities

• Keep abreast of all relevant laws, regulations and corporate governance requirements including data privacy, Charities Act etc.
• Develop, review, and update compliance policies and procedures. Ensure policies align with the relevant laws and regulations.
• Ensure timely submissions to the relevant authorities.
• Support the Board, Executive Committee, and Audit and Risk Management Committee meetings.
• Support maintenance of the enterprise risk management framework including working with key risk owners and stakeholders to identify new risks and develop/review risk mitigation plans.
• Support management reporting to key stakeholders including the board.
• Manage the scientific publications database and coordinate with key stakeholders on performance monitoring and to prepare presentations and reports to key stakeholders.
• Any other duties assigned by the Reporting Officer.

Requirements

• Bachelor’s degree in law, business, finance, or a related field.
• Minimum 5 years of relevant experience in compliance.
• Strong project management and organizational skills.
• Strong analytical skills and attention to detail.
• Ability to work independently and collaboratively in a fast-paced environment.
• Good communication and interpersonal skills.
• Experience with a non-profit organisation or research institution preferred.

Salary and benefits are commensurable to educational qualifications and working experience of the candidates. Benefits include annual leave, medical and flexi-benefits, etc.

Interested individuals may apply by sending their curriculum vitae to jocelyn_pang@tll.org.sg.

For more info, please refer to our website: www.tll.org.sg.

(Please note that only shortlisted candidates will be notified.)

Job Responsibilities

• Work closely with all production team on the production process and oversee the day-to-day operations to ensure compliance with AVA, NEA HACCP guidelines and ISO standards
• Perform the creation and revision of corporate level quality documents that support GMP operations to ensure compliance with GMP guidelines
• Assist to contribute to the maintenance and continuous improvement of the Record Management systems and processes
• Assist to conduct regular risk assessment of corporate compliance against ever-changing Food Safety regulation to identify and work with relevant technology to develop mitigation plan
• Assist to develop Food Safety and Food Defends related standards
• Assist to develop Food Safety and Food Defends training materials
• Assist in driving the implementation of the Food Safety and Food Defends system and prerequisite program ingredient
• Conduct impact assessments and updates to QMS policies
• Manage QMS Management Review meetings according to local SOPs
• Maintain ISO / HACCP documentation and monitoring records update
• Handle all related operations audits
• Work closely with Marketing/ Sales and Production in packaging artwork development by providing product technical information eg. ingredient listings, nutrition labels that comply with labelling regulations of sales countries
• Update internal and external customers on the status of the quality issues
• Assist to ensure appropriate corrective and preventive actions are taken to eliminate detected non-conformance and the causes
• Provide Technical support to Marketing, R&D, Sales & Operations and Business Development teams in terms of product information enquiries from customers and country customs
• Other duties as assigned by the Head of Department

Job Requirements

• Able to communicate with all level and good interpersonal skills
• Knowledge in food labelling regulatory requirements pertaining to product claims, ingredient listing, nutrition labelling and etc.
• Meticulous with good attention to details and an effective change agent

Education, Experience & Training

• Min. Diploma/Degree in Food Technology, Food Science or its equivalent qualifications
• At least 1 year of experience working in SME food manufacturing environment
• With minimum 2 years in Quality Assurance or Quality Management, preferably in Food Industry
• Knowledge of HACCP, ISO22000 & GMP requirement will be advantage

Position

In a challenging and multicultural environment, we seek for a senior Functional tester to join our Core Banking IT department in charge of the development and maintenance of the International Core Banking System of Credit Agricole CIB. This information system is deployed in 25 business units all around the world. The system has multiple modules to manage reference data, commercial back office functions (payments, remittances, loans, deposits, guarantees, letters of credit …), accounting, management control and credit risk monitoring. The system caters to local regulatory reporting needs and head office reporting, based on a data warehouse.

The candidate will be in charge of understanding the requirements and to test the payment system of the bank which is Global Pay Plus – Sevice Platform (GPP-SP) from Finastra (previously D&H). The role will focus primarily on testing the various evolutions of the in-house solution together with the payment engine (GPP-SP).

Main responsibilities

As a Functional Tester:

· Handle the core banking system’s and payment system’s various test phases : regression tests, integration tests, functional tests, test automation

· Good Knowledge and working experience of Software Development Life Cycle (SDLC), Software Testing Life Cycle (STLC) and Defect Life Cycle.

· Define functional test scenarios for core banking and payment systems

· Overall responsible for ensuring End to End testing for all the streams.

· Maintain up to date test libraries (test scenarios, test cases)

· Working with SIT & UAT Testing Team, reviewing, testing scenarios, test cases and helping developers and testers in clearing their doubts about the requirements etc.

· Recording defects utilizing defect tracking tool with priority and severity and alert the management

· Manage planning, communicate with stakeholders

· Prepare regular reports on test results

· Supporting the business users for User Acceptance Testing

· Supporting Operations team / Business Users team to complete the testing

· Managing testing at times when required and found the issues / testing not closing or moving as expected

· Lead Defect Management related actives

Qualifications and Profile

The position requires a minimum of 8-10 years relevant functional tester experience with Payment systems and Core Banking applications.

Functional

· Good knowledge in Payment area like interaction with Clearing, payment file format ISO20022, SEPA and SWIFT. Hands-on experience with such data mapping and testing.

· Hands on experience on payment systems and exposure to Payments Hub, Clearing and Settlement, Automated clearing house programs and channels.

· Extensive knowledge on various kinds of payment products such as TT, RTGS, LVP, Payroll, Cheque, DD, Cashier Order, Mass & Bulk payments.

· Proficient in End to End, Functional & System Integration testing of banking and financial applications

· Experience in following areas is a plus: Retail Banking, Wholesale & Corporate Banking, Corporate commercial Payments, International & Domestic Payments, Payment Hub/Factory, Correspondent Banking, ACH, Real Time Payments, Cash & Liquidity Management, Compliance/AML, FX, Messaging (Swift and ISO)

· Functional testing experience in GPP-SP (Global PayPlus – Service Platform) is mandatory

Technical

· Hands on experience on testing methodologies

· Working knowledge of XRAY/JIRA

Other Professional Skills and Mindset

· Work on complex systems and a challenging international work environment

· Knowledge of all phases of IT testing lifecycle and IT system development and implementation life cycle

· Highly analytic and detail oriented in approach with Excellent communication and presentation skills, with experience converting highly complex information into clear, concise documentation.

· Strong analytic skills

· Capable to effectively interact with multiple stakeholders

· Strives to deliver the solution in the most effective and timely manner

· Proactive with excellent verbal and written communication skills in English

· Team spirit - Like explain and share knowledge

· Hands on and versatile

· As part of an integrated organization across 3 main sites (Paris, SQY, Singapore), be able to forge close relationships with program director, others team leads, architecture functions and quality assurance teams. It could be a limited travel aspect for this role.

Job Responsibilities

Internal Reviews

• Visit subsidiaries and review operations and internal controls with reference to Standard Operating Procedures (SOPs) and Controls Self-Assessment (CSA), reporting inadequacy, lapses or discrepancies and providing recommendations for improvement.
• Liaise with key personnel in subsidiaries to monitor the progress of improvements implementation, at the same time evaluating its effectiveness.
• Assist in the conduct of fraud investigations where necessary.

Risk & Compliance Activities

• Maintain the Group’s finance SOPs, key among them, the subsidiary accounting handbook and supplementary policies, enhancing and updating them periodically.
• Assist in coordination of the Group’s Enterprise Risk Management activities, where top risks of the Group are identified and monitored to reduce risk of occurrence or impacts.
• Coordinate the Group’s FOCIT and Control Self-Assessment programs to have a annual snapshot of the Group and subsidiaries state of internal controls.
• Monitor regulatory changes relating to risk and compliance and assist in its compliance.

Internal Audits

• Liaise with internal auditors, supporting them with the necessary for the completion of the scheduled audits in the Group.

Requirements

• Degree in Accountancy/Business or ACCA with 2 years of relevant experience. Familiarity with accounting systems will be advantageous.
• Team player with strong interpersonal skills.
• Excellent written and verbal communication skills
• Bilingual in English and Mandarin - Will have to liaise to Mandarin speaking counterparts
• Able to work efficiently and effectively
• Possess a good analytical mind, judgment, integrity, and attitude to get to the bottom of things
• Willing to travel overseas. Overseas work encompass about 25% for this role

• The role involves planning, coordinating, and implementing standards development projects under the national standardisation programme administered by Enterprise Singapore.
• Provide secretariat support to the Quality and Safety Standards Committees and its supporting Technical Committees and Working Groups.
• Engage and coordinate with the industry, academia, and government organisations to facilitate the development, promotion, and review of Singapore Standards and Technical References. Include coordinating and organising key standard launches and awareness workshops.
• Responsible for the identification of standards to be developed in consultation with key stakeholders from the industry, the development of standards right up to standard launches.
• Assist in the industry and technical research for the development of new/review of standards. Conduct verification studies to identify users of the standards.
• Handle all enquires received promptly regarding the standards under your area of responsibility.

Requirements

• A relevant Engineering / Quality Management / Workplace / Occupational Health and Safety degree or diploma from a recognised institution.
• Good knowledge of statutory requirements on safety, codes of practice or prior experience as a Safety Officer will be an advantage.
• Preferably with 3 years of industrial experience.
• Good command of spoken and written English.
• Able to write clear and concise minutes of meetings.
• Results-oriented and able to execute projects in a team and independently.
• Strong interest in industry standards development and promotion.
• Possess excellent networking, communication, and industry engagement skills.
• Proficiency in Microsoft Word, Excel, PowerPoint, and other productivity tools

About ESG Book 

ESG Book is a global leader in sustainability data and technology. Launched in 2018, ESG Book offers a wide range of ESG-related data, analytics and software that are used by many of the world’s largest financial institutions. 

Covering more than 50,000 companies, ESG Book’s product includes ESG and climate data, portfolio and company-level scores, and analytics tools. ESG Book’s SaaS data management and disclosure platform provides access to over 190,000 corporate disclosures, enabling companies to disclose to stakeholders in real-time against multiple frameworks. 

Headquartered in London, ESG Book operates from key financial hubs globally including Frankfurt, Boston, New York, Delhi, and Tokyo.  

ESG Book as a company is built on 3 pillars: 

1. Collective Endeavour – we embrace entrepreneurialism and work together to drive new thinking, solutions, and change. 
2. Caring Meritocracy – we support people and teams to maximize their potential; individually, collectively, collaboratively. 
3. Radical Transparency – we are open, challenging, and constructive for the advancement of our mission. 

Our ambition is to support our clients to build a more sustainable economy. Our core values guide our daily actions as we strive to create lasting change. Our open, collaborative culture provides a nurturing environment for personal and professional growth, enabling us to achieve remarkable outcomes for our clients and stakeholders. 

e are looking to hire new Data Quality Analyst with experience in data analysis to join our team and contribute to ESG Book’s global growth. You will be responsible and accountable for contributing to grow ESG Book’s data products and for ensuring high content quality.

We Are Keen To Hire Professionals Who

·         have 1-3 years’ experience in Data Analysis

·         Have expert level working experience in Python and being comfortable to handle basic data structures (e.g., list, dictionary) and language features (e.g., list comprehension).

·         are familiar with articulating analytical viewpoints and work with attention to detail 

·         possess excellent knowledge of the tools - MS Office Suite, Python, SQL

·         Good to have Power BI, R

·         possess good knowledge of Data visualization, data modelling, statistical analysis,

·         advance in MS Excel

·         are proficient in English — oral, written and comprehension

·         are not afraid of new empirical challenges and learning a new area of expertise

·         are motivated and passionate about ESG data and climate change

What We Offer 

• A fast-paced environment filled with passionate people from diverse backgrounds who share a common purpose and global outlook 
• The opportunity to advance your knowledge of environmental, social and governance topics while supporting the world’s largest financial institutions and corporations to create a more sustainable future 
• Collaboration as part of a highly motivated, experienced and easy-to-work with Executive Team who are focused on building a great company that delivers for clients and stakeholders alike 
• Exposure to a large, dynamic market that has the potential to positively impact society for decades to come 
• Competitive benefits and equity ownership in a business that is well positioned to capitalize on the increasing demand for high-quality sustainability data and secure enterprise disclosure platforms 

 

We are an equal opportunities employer. This belief and approach apply to all aspects of employment, including recruitment and selection, opportunities for training, development and promotion and our terms and conditions of engagement. 

Main responsibilities

As a Functional Tester:

• Handle the core banking system’s and payment system’s various test phases : regression tests, integration tests, functional tests, test automation
• Good Knowledge and working experience of Software Development Life Cycle (SDLC), Software Testing Life Cycle (STLC) and Defect Life Cycle.
• Define functional test scenarios for core banking and payment systems
• Overall responsible for ensuring End to End testing for all the streams.
• Maintain up to date test libraries (test scenarios, test cases)
• Working with SIT & UAT Testing Team, reviewing, testing scenarios, test cases and helping developers and testers in clearing their doubts about the requirements etc.
• Recording defects utilizing defect tracking tool with priority and severity and alert the management
• Manage planning, communicate with stakeholders
• Prepare regular reports on test results
• Supporting the business users for User Acceptance Testing
• Supporting Operations team / Business Users team to complete the testing
• Managing testing at times when required and found the issues / testing not closing or moving as expected
• Lead Defect Management related actives

Requirements:

• Min. 8-10 years relevant functional tester experience with Payment systems and Core Banking applications.

Functional

• Good knowledge in Payment area like interaction with Clearing, payment file format ISO20022, SEPA and SWIFT.
• Hands-on experience with such data mapping and testing.
• Hands on experience on payment systems and exposure to Payments Hub, Clearing and Settlement, Automated clearing house programs and channels.
• Extensive knowledge on various kinds of payment products such as TT, RTGS, LVP, Payroll, Cheque, DD, Cashier Order, Mass & Bulk payments.
• Proficient in End to End, Functional & System Integration testing of banking and financial applications
• Experience in following areas is a plus: Retail Banking, Wholesale & Corporate Banking, Corporate commercial Payments, International & Domestic Payments, Payment Hub/Factory, Correspondent Banking, ACH, Real Time Payments, Cash & Liquidity Management, Compliance/AML, FX, Messaging (Swift and ISO)
• Functional testing experience in GPP-SP (Global PayPlus – Service Platform) is mandatory

Technical

• Hands on experience on testing methodologies
• Working knowledge of XRAY/JIRA

Other Professional Skillset & Mindset:

• Able to work on complex systems and a challenging international work environment
• Knowledge of all phases of IT testing lifecycle and IT system development and implementation life cycle
• Highly analytic and detail oriented in approach with Excellent communication and presentation skills, with experience converting highly complex information into clear, concise documentation.
• Strong analytic skills
• Capable to effectively interact with multiple stakeholders
• Strives to deliver the solution in the most effective and timely manner
• Proactive with excellent verbal and written communication skills in English
• Team spirit - Like explain and share knowledge
• Hands on and versatile
• As part of an integrated organization across 3 main sites (Paris, SQY, Singapore), be able to forge close relationships with program director, others team leads, architecture functions and quality assurance teams. It could be a limited travel aspect for this role.

Interested applicants, please email your resume to Shaun Quek Yew Meng

Email: shaunquek@recruitexpress.com.sg

CEI Reg No: R1660732

EA Licence No: 99C4599

Job Summary

The Quality Assurance & Regulatory Affairs, Executive will report to the Regulatory Affairs & Quality Assurance, Manager and he/she will assume primary responsibility in providing quality assurance and control expertise to the Menarini team and Partners; and support the Regulatory Affairs & Quality Assurance, Manager in the regulatory affairs and quality assurance functions. He/she will also be responsible to undertake regulatory project management and ensure regulatory compliance in Singapore as required.

Job Responsibilities

• Prepare and conduct QMS audits with management review in accordance with SS 620 GDPMDS and/or HSA GDP requirements
• Prepare, review and maintain QMS required SOPs and ensure proper documentation in accordance with SS 620 GDPMDS and/or HSA GDP requirements
• Process and report product quality complaints/product defect to the authority, Regional and/or Partners. Review complaint investigations, CAPA plan and effectiveness review and monitoring of complaint trends and reporting the trends
• Manage deviations and CAPA and ensure timely investigation, closure and implementation
• Review and submit change controls to assess the impact of change and ensure timely implementation
• Liaise with distributor on the secondary repackaging requirements and prepare repackaging instructions and request forms
• Ensure product specifications, labels and related documentation are in alignment with current registered information
• Coordinate post marketing surveillance activities such as FSCA and product recalls
• Ensure compliance is in place for all product post market registration conditions
• Provide training for internal stakeholders on quality SOPs and ensure compliance with company policy
• Maintain database of registrations, change controls, deviations and product quality complaints
• Planning, preparing and submitting new marketing authorization applications for Singapore
• Planning, preparing and submitting post approval changes including variations, change notifications, renewals etc. for Singapore and work with relevant stakeholders to ensure business continuity
• Liaise with the local authorities to ensure timely regulatory approvals in meeting business plans
• Develop regulatory strategies during the preparation of new application, renewal and variation submissions to address gaps and communicate its impact
• Review and approve labels and promotional materials for regulatory compliance
• Supports any other relevant activities or as required

Requirements

• Candidate must possess at least a Bachelor's Degree in Science, Engineering or Pharmacy
• Understanding of regulatory standard related to cGMP, GDP, SS620, PIC/S, ISO 13485 and cold chain management
• Certified internal auditor for GDPMDS or ISO13485 is required
• Experience in audit, QA batch management, complaint management, deviation management, change control management, CAPA and recall management
• Minimum 2 years’ experience in commercial quality assurance in pharmaceutical or medical device industry
• Regulatory experience in therapeutic products, medical devices, cosmetics, traditional medicine and/ or health supplement is a bonus
• Ability to work both as an individual and as a team player
• Ability to influence and collaborate with people at all levels effectively
• Proficient in both oral and written English
• Computer literate
• Attention to details and results oriented
• Flexible and adaptive to changes

What’s the role?

Your primary accountabilities as a Process Control Senior Engineer includes:

• Improve robustness of Base Layer control performance, delivery of high uptime and low operator intervention rates.
• Conduct daily base layer performance monitoring, provide technical support and lead troubleshooting for control and safeguarding related issues.
• Maximize benefits from optimization applications through the implementation of unit wide Advanced Process Control (APC) and Real Time Optimization (including Advanced Analytics) systems.
• Sustain the performance of existing APC and optimization systems.
• Identify opportunities for improvements in the area of control strategy and control configuration.
• Design, modify and tune base layer controls and Advanced Process Control applications to maximize benefits and save energy.
• Support Production team activities for e.g. alarm management and ensure plan delivery
• Participate in design or safety review and provide process control and safeguarding related inputs to projects.
• Participate in major activities like factory acceptance and site acceptance tests for Distributed Control System (DCS), Oil Movement System (OMS) and Instrumented Protective System (IPS) systems and unit startup support.
• Contribute to multifunctional teams in site wide initiatives, such as unit shutdown/startup preparation and coordination.
• Lead and engage with other engineers from Shell to maximize value delivered from process automation, control and optimization technology.
• Guide and coach, the less experienced process control staffs and help develop their technical competences.
• Demonstrate strong learner mindset and commits to be digitally literate to drive value creation through digitalisation.

What we need from you

We are keen to speak to individuals with the following:

• Chemical engineer or similar background by either education or by experience
• Knowledge of oil/chemical manufacturing processes
• At least 6-8 years of relevant Process Control experience in oil/gas industry.
• Knowledge competency level for APC technology such as PACE
• Knowledge competency level with Yokogawa DCS system and ability to execute engineering changes.
• Be able to tune, design and implement process control loops independently.
• Excellent written and verbal communication skills, and interpersonal relation skills.
• Good collaboration and team working skills, with a keen ability to develop a good rapport with Process Operating teams.
• Be able to prioritize and manage expectations in the case of competing requests from stakeholders.
• Familiarity with Yokogawa DCS & Prosafe
• Knowledge in Process Automation Systems Engineering
• Knowledge in Safety Instrumented Systems and Safeguarding
• Knowledge in Advanced Process Control and Modelling & Real Time Optimization
• Knowledge in Compressor Control
• Skilled in Base Layer Control

If you don’t see yourself reflected in the job requirements on the posting above, we still encourage you to reach out and apply. Shell is committed to creating a more diverse, equitable and inclusive workplace and we encourage individuals of all backgrounds to send in your applications.

Company Description

Shell is an international energy company that uses advanced technologies and takes an innovative approach to help build a sustainable energy future. Here in Singapore, Shell has a long history and is one of the country’s largest foreign investors. It has businesses spanning trading and marketing of liquefied natural gas; refining, trading, marketing and shipping of oil products, lubricants and chemicals; low carbon solutions; and operating a network of service stations through retailers, as well as electric vehicles charging.

An innovative place to work

There’s never been a more exciting time to work at Shell.

Join us and you’ll be adding your talent and imagination to a business with the ambition to shape the future – whether by investing in oil, gas, and renewable energy to meet demand, exploring new ways to store energy, or developing technology that helps the world to use energy more efficiently, everyone at Shell does their part.

An inclusive place to work

To power progress, we need to attract and develop the brightest minds and make sure every voice is heard. Here are just some of the ways we are nurturing an inclusive environment – one where you can express your ideas, extend your skills, and reach your potential.

• We’re creating a space where people with disabilities can excel through transparent recruitment process, workplace adjustments and ongoing support in their roles. Feel free to let us know about your circumstances when you apply, and we’ll take it from there.
• We’re closing the gender gap – whether that’s through action on equal pay or by enabling more women to reach senior roles in engineering and technology.
• We’re striving to be a pioneer of an inclusive and diverse workplace, promoting equality for employees regardless of sexual orientation or gender identity.
• We consider ourselves a flexible employer and want to support you finding the right balance. We encourage you to discuss this with us in your application.

A rewarding place to work

Combine our creative, collaborative environment and global operations with an impressive range of benefits and joining Shell becomes an inspired career choice.

We’re huge advocates for career development. We’ll encourage you to try new roles and experience new settings. By pushing people to reach their potential, we frequently help them find skills they never knew they had, or make career moves they never thought possible.

A full description of the role is available in the attachment: job description. Please note that if a high number of applications are received this advert may close early. You are advised to submit you application at the earliest opportunity. Working for the Trust Across our organisation, people are guided by values that were co-developed with staff: we are kind; we are open; and we pursue excellence. Our values play into our ambition to develop a more diverse workforce, truly representative of our communities. We welcome applications from everyone, while working with our Staff Networks - including our Race Equality, LGBTQ+, Disability and Carers Networks - to increase the number of applications we receive from different backgrounds. If there is anything we can do to make our application process more accessible to you, please contact: yhs-tr.recruitment@nhs.net. As part of seeking to become more inclusive, we will consider requests for flexible working from the start of your employment. It may not be suitable for every role, but we will try and be supportive where we can. We would encourage you to speak to the recruiting manager named within this advert to discuss any requirements you may have. Armed Forces Friendly Employer We are holders of the Gold Award from the Defence Employer Recognition Scheme, which is helping actively promote SaBRE - Supporting Britains Reservists and Employers. This means that we have made a statement of intent to support all Defence personnel, including with applications for employment. COVID-19 Vaccination Requirements Our Trust continues to strongly encourage our staff to be vaccinated against COVID19, this remains our best defence to protect our patients, ourselves and everyone else.

A Vacancy at York and Scarborough Teaching Hospitals NHS Foundation Trust.


An opportunity has arisen for a motivated and enthusiastic pharmacy technician to join the Pharmacy Quality Assurance team based at York Hospital.

The Quality Assurance Team ensures that the quality of pharmacy services is effectively monitored and continually improves. As a member of this team, you will help implement and maintain all aspects of the pharmacy quality management system. You will monitor, test and maintain assets, such as the Trust fridge temperature monitoring and delivery systems. You will monitor the safe use of medical gases throughout the Trust. You will undertake and review audits and self-inspections for pharmacy services and the use of medicines. You will also write and review quality reports and participate in departmental quality meetings and audits for the Safe & Secure Handling of Medicines, Aseptics & Radiopharmacy and controlled drugs

We strive to develop the knowledge and skills of our workforce to enable them to advance personally and professionally and this is the ideal career development prospect. You will need to demonstrate excellent written and verbal communication skills, be very well organised and able to work both independently and as part of a multidisciplinary team.

This post is open as a Band 5 position. Although we welcome applications for a developmental Band 4-5 position from pharmacy technicians registered within the last year or who will shortly be registered. This will be discussed at interview.

This post holder is responsible for quality assurance (QA) in the pharmacy department. The successful candidate will ensure compliance with legislation and medicines management standards.

Tasks include:
• Daily management of the Quality Management System, including document control, asset monitoring & management of deviations
• Writing quality reports
• Management of medical gas cylinders
• Temperature monitoring
• Report product defects
• Management of unlicensed medicines
• Internal audits and implement actions
• Health and safety

Recent experience of working as a pharmacy technician within a hospital environment is essential. Experience of working in aseptics or QA would be helpful but not essential as training will be given. All candidates should be positive about the extended role of pharmacy technicians and keen to develop themselves, their role and work of the team. You must be a qualified accredited checking technician (ACPT) or be willing to work towards this.

You will be based in the pharmacy department in York Hospital but may be required to work at other Trust on occasion. Core service hours are Monday to Friday 08:45 – 17:15. You will contribute to the weekend rota (1 in 8 weekends) and bank holiday rota (1 per year). You will have a regular dispensary slot once a week where you will dispense or conduct final accuracy as part of the accredited checking pharmacy technician (ACPT) led dispensary service.

Please see attached additional information document

Our benefits

We offer a range of benefits to support our staff including:
• Access to the NHS Pension Scheme, providing generous benefits upon retirement, as well as a lump sum and pension for dependants
• 27 days holiday rising to 33 days (depending on NHS Trust service)
• A generous relocation package of up to 30% of salary (capped at £18k) to support with relocation expenses for hard to fill positions where relocation would be an expectation to undertake the role fully. If you would like to discuss a potential relocation package, please speak to the recruiting department/manager at interview stage.
• A variety of different types of paid and unpaid leave covering emergency and planned leave
• Confidential advice and support on personal, work, family and relationship issues, 24/7, from our Employee Assistance Programme
• NHS Car Lease scheme and Cycle to Work scheme
• An extensive range of learning and development opportunities
• Discounts on restaurants, getaways, shopping, motoring, cinema and finance from a range of providers

For further information on the fantastic range of benefits we offer please visit the Trust's dedicated Staff Benefits pages.

A full description of the role is available in the attachment: job description.

Please note that if a high number of applications are received this advert may close early. You are advised to submit you application at the earliest opportunity.

Working for the Trust

Across our organisation, people are guided by values that were co-developed with staff: we are kind; we are open; and we pursue excellence.

Our values play into our ambition to develop a more diverse workforce, truly representative of our communities. We welcome applications from everyone, while working with our Staff Networks - including our Race Equality, LGBTQ+, Disability and Carers Networks - to increase the number of applications we receive from different backgrounds. If there is anything we can do to make our application process more accessible to you, please contact:yhs-tr.recruitment@nhs.net.

As part of seeking to become more inclusive, we will consider requests for flexible working from the start of your employment. It may not be suitable for every role, but we will try and be supportive where we can. We would encourage you to speak to the recruiting manager named within this advert to discuss any requirements you may have.

Armed Forces Friendly Employer

We are holders of the Gold Award from the Defence Employer Recognition Scheme, which is helping actively promote SaBRE - Supporting Britain’s Reservists and Employers. This means that we have made a statement of intent to support all Defence personnel, including with applications for employment.

COVID-19 Vaccination Requirements

Our Trust continues to strongly encourage our staff to be vaccinated against COVID19, this remains our best defence to protect our patients, ourselves and everyone else.


This advert closes on Wednesday 18 Sep 2024

Proud member of the Disability Confident employer scheme

Senior Engineer - Control Systems
Job no: RR Work type: Permanent - Full Time Location: Telfer Operation
Newmont has recently acquired Newcrest Mining creating the worlds leading gold mining company. 
With operations around the world, our workforce reflects the diversity of the communities where we operate. We aim to create an inclusive environment where everyone feels safe, valued, and supported to bring their whole unique self to work. We bring out the best in each other, inspiring performance and a shared belief that what we do matters. 
Operations near and far
In the Great Sandy Desert in the East Pilbara region of Western Australia, our Telfer gold-copper mine is our fly-in-fly-out operation, comprising open pits, processing plant and an underground mine. While at site Telfer offers a diverse range of recreational activities including a gym, swimming pool, driving range,
... Click here to view more detail / apply for Senior Engineer ? Control Systems