Total 47 job vacancies by Pharmagend Global Medical Services Pte. Ltd.

KEY DUTIES AND RESPONSIBILITES:

• Perform analysis and tests of drug products, raw materials, in-process materials, release test samples, stability samples, packaging materials, quantitative assays on samples, and/or finished products from manufacturing, to ensure quality standards and compliance with established specifications.
• Preparation of reagents/diluents/ dissolution media as per STP.
• Perform various qualitative tests or qualitative assays on samples using modern and automated instrumentation.
• Utilize electronic laboratory information systems such as LIMS for acquisition and processing of analytical data.
• Ensure implementation of SOP for all corresponding activities.
• Write controlled documentation related to QC Laboratory operations or testing such as SOP's, analytical protocols, analysis reports and forms.
• Ensure real time documentation, maintain data integrity and appropriate traceability.
• Assist in maintenance and calibration of test instruments per specifications.
• Responsible for the accurate, timely and compliant execution of assigned projects, analytical testing and related documentation.
• Responsible for checking all results in LIMS/RDS and reporting of any observed results that do not meet the requirement (OOS/OOT/Deviation) for further investigation.
• Destruction of expired finished products/ raw material samples as per SOP and recording the same in the register.
• Responsible for QC lab and equipment/instrument cleanliness.
• Responsible for procuring and receipt of QC lab glassware and consumables.
• Any other activities as and when assigned by the Superior.

REQUIREMENT

• Possess working knowledge of GMP in the pharmaceutical industry.
• A good team player with a positive learning attitude.
• Working knowledge of validation, calibration and operation of laboratory equipment such as HPLC, GC, FTIR and Dissolution equipment.
• EDUCATION & EXPERIENCE
• Degree / Diploma in science related discipline (e.g. Chemistry, Chemical Engineering).
• (Specialist) Minimum 4 years of quality control experience in pharmaceutical manufacturing industry.
• (Analyst) Fresh grad/ 1-2 years of quality control experience in pharmaceutical manufacturing industry.

• Responsible for office’s day to day HR & administrative related work duties
• Posting job advertisements for vacancies and coordinate interview with candidates.
• Managing employee and company insurance.
• Prepares employees for assignments by establishing and conducting orientation (fingerprint registration) and training programs.
• Responsible for up-to-date employee data TMS record.
• Prepare and coordinate worker's work permit application / renewal / cancellation.
• Coordinate HR events and staff welfare activities
• Assist in admin duties such as staff leave administration and medical claims.
• Manage and supervise the Office Admin functions such as office supplies, equipment, facilities repairs and maintenance.
• Liaison with inter-departments on necessary work coordination.
• Assist in travel arrangements and accommodation bookings for employees and visitors.
• Other duties as assigned by management.

Requirements:

• At least 3 years of relevant working experience in the related field.
• Good in written communication.
• Computer literate with strong proficiency in Microsoft Office applications.
• Good knowledge of Employment Act, MOM regulations and practices
• Experience in HR software will be advantages

1. Lead a performing Engineering team covering utilities, facilities, and warehouse for the manufacturing site.
2. Achieve financial objectives through efficient utility operation, cost improvement actions and optimal cost options.
3. Planning & execution of all new and retrofit projects related to utilities & facilities.
4. Ensuring the best available technologies are incorporated by design.
5. Techno commercial evaluations of consultants, vendors, and contractors.
6. Delivering the project within the budget and timeline approved.
7. Responsible for relevant project costing and annual budget preparation related to engineering, facilities and EHS.
8. Coordinating with statutory authorities for relevant approvals.
9. Complying with operational and personnel standards, regulatory and statutory requirements to ensure efficient, reliable, and uninterrupted operation.
10. Ensure smooth handing over of the project to end-users, coordinate and ensure deliverables as per plan.
11. Ensure the site's facilities are kept to the highest standards for cGMP requirements, including Purified water system, HVAC system, EMS, BMS,Boilers, fire safety, security, pest control, cleaning services and waste removal.
12. Responsible for utilities & Facilities equipment Operation, Maintenance, Calibration, spares management and drawings management.
13. Responsible for development SOPs and quality standard for site with following of site QMS procedures.
14. Ensure to meet required the regulatory requirements (e.g. HSA, FDA etc.) and keep site audit ready all the time.
15. Responsible for managing a team of vendors / contractors.
16. To assist on any ah-hoc duties that been assigned / task by the immediate superior.

Qualification

1. Degree or Diploma in Engineering with a minimum of 5-10 years of relevant experience.
2. SCEM will be an added advantages.

KEY DUTIES AND RESPONSIBILITES:

• Preparation and review of qualification documents e.g., User requirement specification, DQ, IQ, OQ and PQ protocol for equipment, utilities & facility in compliance with the regulatory guidelines.

• Execution of qualification and validation activities including process, cleaning, computer system, equipment, utilities, and facility.

• Candidate must have knowledge and experience of qualification/validation principles and their practical application.

• Preparation and review of process and cleaning validation protocols and reports.

• Coordinate with the cross functional team and external service provider to meet qualification & validation schedules and maintain equipment, systems, and processes in validated state.

• Review equipment and process related change control; perform Risk Assessment to determine criticality of the proposed changes.

• Write, review, and revise validation SOPs in compliance with regulatory guidelines.

• QA oversight and/or review during the validation process.

• Manage incidents and deviations related to validation & qualification.

• Perform compliance reviews of all applicable deviations, investigations, and CAPAs related to qualification and validation.

• Review and suggest continuous improvements to the Validation Master Plan, current quality system practices, validation protocols and procedures for newly installed equipment, and overall validation strategies.

• Cross train and develop expertise in other areas of validation.

• Must be able to interact and lead effectively in a team-based environment.

• Familiarity with regulatory/compliance environment.

EDUCATION & EXPERIENCE:

• Degree a scientific discipline or equivalent.

• Experience in a regulated industry preferred.

• A minimum of 5-7 years’ relevant experience in pharmaceutical manufacturing environment.

• Proficient in the use of Microsoft Word, Excel, Access, PowerPoint, and Explorer.

KEY DUTIES AND RESPONSIBILITES:

• Perform various activities and tasks required in the tablet coating production areas.

• Operate all relevant equipment, clean, assemble and maintain the cleanliness of the equipment.

• Perform and maintain the documentation of operations in accordance with cGMP requirement.

• Operate the equipment appropriately in accordance with Standard Operating Procedure / batch document.

• Perform online monitoring of in process parameters / checks throughout the batch.

• Complete all relevant records and other documentation required for tablet coating, maintenance and cleaning of equipment in the work area.

• Perform all activities in accordance with cGMP.

• Maintain the cleanliness of work area to ensure cGMP compliance.

• Perform all other relevant duties required to meet the schedule.

• Check relevant material and product details against batch document

• Co-ordination with Engineering for break down rectification of coating and related solution mixing equipment.

• Involve in equipment / process qualification.

• Participate in investigation of process deviation, cGMP and all other compliance related matters, where applicable.

• Ensure compliance to GxP / Safety / Quality policies.

REQUIREMENT

• Good understanding of safe working practices and cGMP.

• Experience in tablet coating of oral solid dosage manufacturing is preferred.

• A good team player with positive learning attitude.

• Willing to work in Tuas area, in cleanroom environment with full gowning.

EDUCATION & EXPERIENCE

• Minimum GCE 'O' level or NITEC or Higher NITEC or Diploma in Biotechnology / Biomedical / Mechanical / Mechatronics Engineering or relevant disciplines

• With 2-5 years of manufacturing experience in Pharmaceutical or related industries.

• Entry level NITEC / Higher NITEC / Diploma candidates are welcome to apply.

1. Perform analysis and tests of drug products, raw materials, in-process materials, release test samples, stability samples, packaging materials, quantitative assays on samples, and/or finished products from manufacturing, to ensure quality standards and compliance with established specifications.
2. Preparation of reagents/diluents/ dissolution media as per STP.
3. Perform a various qualitative tests or qualitative assays on samples using modern and automated instrumentation.
4. Utilize electronic laboratory information systems such as LIMS for acquisition and processing of analytical data.
5. Ensure implementation of SOP for all corresponding activities.
6. Write controlled documentation related to QC Laboratory operations or testing such as SOP's, analytical protocols, analysis reports and forms.
7. Ensure real time documentation, maintain data integrity and appropriate traceability.
8. Assist in maintenance and calibration of test instruments per specifications.
9. Responsible for the accurate, timely and compliant execution of assigned projects, analytical testing and related documentation.
10. Responsible for checking all results in LIMS/RDS and reporting of any observed results that do not meet the requirement (OOS/OOT/Deviation) for further investigation.
11. Destruction of expired finished products/ raw material samples as per SOP and recording the same in the register.
12. Responsible for QC lab and equipment/instrument cleanliness.
13. Responsible for procuring and receipt of QC lab glassware and consumables.
14. Any other activities as and when assigned by the Superior.

KEY DUTIES AND RESPONSIBILITES:

• The role involves leading all compounding and sterile filling activities, as well as being responsible for the secondary packaging of final finished goods.
• Ensuring safe work environments, enforcing operational discipline, and monitoring aseptic behaviors.
• Efficiently utilize tools and metrics (KPI’s) to monitor staff productivity, deliverables, timelines, and quality of work product to adjust staffing levels and operational processes as needed to ensure operational effectiveness.
• Support investigations, own CAPAs, and drive continuous improvements throughout operations.
• Responsible for developing staffs’ performance goals, maintaining positive employee morale and relations and managing paid time off
• Understanding of the importance/impact of cGMP standards.
• Responsible for handling disciplinary actions and/or Performance Improvement Plans, terminations, escalating complex employee issues to their manager or human resources and ensuring a fair and consistent approach with all team members.
• Identifying potential process/product improvements and working collectively with cross-functional teams to implement process/procedure updates.
• Demonstrates strong industry knowledge and comprehensive understanding of business processes.
• Demonstrates technical/functional expertise in applicable discipline and acquires knowledge in related disciplines.
• Utilize industry technical/functional experience to help develop standard operating procedures.

REQUIREMENT

• Able to establish robust processes, develop performance standards, track performance through fact driven exercises, and implement solutions to drive continuous process improvements.
• Demonstrates skills to solve complex problems in highly regulated environments.
• Previous experience working with auditors, inspectors, and regulatory agencies.
• Able to articulate difficult and complex situations in a comprehensive and succinct manner utilizing professional tools, and deliberate facts.
• Ability to drive a culture of partnership and accountability.

EDUCATION & EXPERIENCE

• Minimum of a Bachelor Degree in a life science, pharmacy, or engineering discipline required.
• Advanced degree/certification preferred. It will be an advantage to the candidate if he/she is a registered pharmacist in Singapore.
• 5-8 years manufacturing or engineering experience, preferably in sterile manufacturing and a good understanding of quality and compliance standards of various agencies, including US-FDA, European EMA and China NPMA.
• 3-5 years management experience; with no fewer than 20 direct/indirect reports.
• Proven effective verbal and written communication skills.
• Experience working with SAP, QMS such as TrackWise.

KEY DUTIES AND RESPONSIBILITES:

• Organise board meetings and ensure relevant documents are distributed to the Directors and Stakeholders.
• Liaising with the Board of Directors & Stakeholders on meetings and announcements.
• Managing and drafting of all corporate confidential documents, inclusive legal agreements, engagement contracts, ACRA filing, meeting minutes, board resolutions, annual report. Meeting presentation deck.
• Compile and close monitoring of all statutory licences for the company.
• Support both the CEO & President on all administrative task and to follow thru with the relevant stakeholders timely.
• Managing the CEO & President’s calendar and to make travel plan, booking and meeting event appointment appropriately.
• Organized and co-ordinate on any company events when required.
• Arrange, co-ordinate and as the point of contact for visitors and statutory agencies visiting to site, inclusive receiving and networking with them.
• Other ad-hoc duties as requested by the Management.

JOB REQUIREMENTS:

• Bachelor’s degree in Secretarial / Business Studies or equivalent with at least 5 years relevant working experience, preferably with at least 2 years of legal corporate secretary working exposure.

KEY DUTIES AND RESPONSIBILITES:

· Establish the optimal production volumes based on demand, analyzing rough cut capacity, resource planning and detailed equipment planning.

· Create Supply Plan at site level which incorporate production plan and release plans to ensure that the production plans are accurately reflected in ERP System.

· Assess the impact of production plan on the budget operation costs and inventory.

· Work with MSAT function to ensure new product transfers and CMC activities are planned as per customers’ requirement.

· Manage the sites delivery schedule on time in full (OTIF), ensuring that product is produced, released & shipped on time.

· Ensure high “Customer Service Level” ensuring up to date information with customers regarding delivery promises and inventory levels.

· Ensure direct communication with Customers / next point of supply chain, plant-internal and -external stakeholders & partners with regard to internal changes.

· Represent the point of contact for follow-up on time delivery dates and quantities & escalating changes related to supply.

· Optimize local planning processes such as lead times, planning policies and production frequencies to increase the efficiency of the production unit.

· Own and manage the planning parameters in ERP System like MOQ, campaign size, product segmentation.

· Manage procurement activities related to buying of pharmaceuticals ingredients and packing components in accordance with Company requirements and industry compliance.

· Support capital projects with budget more than US$10-20 millions in procurement of machineries and related engineering services.

· Conduct Request For Quotation (RFQ) and work with relevant department on final vendor selection

· Identify and develop purchasing strategies to meet internal stakeholders and external customers’ requirements.

EDUCATION & EXPERIENCE

· Education Level - Bachelor's degree in science or business

· Experience - 5 years planning/procurement experience in manufacturing environment and minimum 2 year experience in the pharmaceutical industry.

· In-depth experience with SAP system

· People management: leadership, cooperative, ability to influence

· Excellent critical thinking and problem solving capabilities

· Teamwork, influencing, communication skills, negotiation, conflict management

· Effective problem analysis and problem-solving

KEY DUTIES AND RESPONSIBILITES:

• Perform receipt of incoming raw and packaging materials.

• Maintain and update documents related to Delivery - Acknowledgments, Goods Receipt Note along with supporting documents.

• Ensure that materials are kept as per the storage conditions.

• Perform dispensing and sieving of raw materials for production use. Perform cleaning of accessories used and the dispensing booth I area after completion of the dispensinq activities.

• Issue packaging materials for packing use.

• To give the planned output dispensing and sieving of raw materials.

• Regularly verify physical stock, review against system stock and identify discrepancies.

• Perform performance checks for the weighing balances (as required). Coordinate for calibration / preventive maintenance for all Warehouse equipment and instruments.

• Intimate and follow up with Maintenance department for breakdown rectification of Warehouse equipment.

• To ensure maintenance of Warehouse area and equipment in the state of cleanliness as per SOP.

• Assist in performing routine check and ensure proper cleaning of premises by contract cleaner.

• Assist in investigation in case of any process deviation, non-compliance.

• To carry out preventive and corrective actions for observed non-conformances.

• Assist in installation and qualification of Warehouse equipment.

• Ensure compliance to GxP /Safety/ HSE / Quality policies.

• To coordinate with QC for sampling of raw and packaging materials. Arrange sampling activity and cleaning of sampling booth.

REQUIREMENT

• Good understandinq of safe workinq practices and cGMP.

• A good team player with positive learning attitude.

• Willing to work in Tuas area, in warehouse and dispensing environment.

EDUCATION & EXPERIENCE

• Minimum GCE 'O' level or NITEC or Higher NITEC or Diploma in Warehouse/ Logistics or relevant disciplines

• Preferably with 3 years' relevant experience in Pharmaceutical manufacturing warehouse/ store operation.

• Entry level NITEC / Higher NITEC / Diploma candidates are welcome to apply.

Job Description:

• Responsible for identifying deviations in the processes and ensure that all activities are cGMP compliant, identifying corrective actions, establishing path forward activities, and appropriate documentation.
• The In-Process Quality Assurance Associate (IPQA) will focus on initial deviation investigative phases related to manufacturing process deviation.
• Facilitates the use of existing management processes regarding deviations, investigations, and preventive actions.
• Performs area assessments and ensures compliance with SOPs, Policies and Procedures.
• Responsible for responding to customer needs immediately, ensuring appropriate corrective action is taken and process controls are in place.
• Work closely with Quality Engineers and QA Management to ensure thorough and complete investigation activities.
• Administration and management of deviations/investigation in Trackwise.
• Execute the final release inspection of packaging lines.
• Perform acceptance sample analysis for validation and investigation support.
• Responsible for the review and approval of controlled documents.
• Actively communicate with customers to facilitate continuous process improvement.
• Adheres to all applicable procedures, cGMPs, company policies and any other quality or regulatory requirements. (For example: FDA etc.)

QUALIFICATIONS:

• Minimum Associate’s degree in scientific discipline or closely related technical field of study is required.
• 1-3 years of pharmaceutical and FDA is preferred.
• Understanding of the production processes used in the Pharmaceutical Industry.
• GMP experience is required.

1. Perform analytical equipment lifecycle management as per current regulatory requirements / SOP.
2. Involve in equipment qualification, writing URS, reporting and implementing SOP’s for system operation and maintenance, monitoring performance of the equipment and decommissioning of equipment.
3. Ensure real time documentation, maintain data integrity and appropriate traceability.
4. Support and / or perform maintenance / calibration of laboratory equipment in compliance with established schedules.
5. Liaise with vendors/service providers for PM / Calibration in a timely manner.
6. Responsible for maintenance / calibration planning of equipment within QC Department.
7. Responsible for the accurate, timely and compliant execution of assigned projects and related documentation.
8. Assist / perform method validation and transfer as required.
9. Conduct QC Department equipment operation and maintenance training to QC staff as required.
10. Perform and / or support in maintaining the asset register for equipment in the QC Department.
11. Initiate CAPEX for equipment purchase.
12. Responsible for QC lab and equipment/instrument cleanliness.
13. Any other activities as and when assigned by the Superior.

EDUCATION & EXPERIENCE:

EDUCATION: Degree / Diploma in science related discipline (e.g. Chemistry, Chemical Engineering, Biotechnology).

EXPERIENCE: Minimum 4 years of quality control experience in pharmaceutical manufacturing industry.

KNOWLEDGE & SKILLS:

1. Possess working knowledge of GMP in the pharmaceutical industry.
2. A good team player with positive learning attitude.
3. Working knowledge of validation, calibration and operation of laboratory equipment such as HPLC, GC, FTIR and Dissolution equipment.
4. Excellent interpersonal and analytical skills, good verbal and written communication skills.

KEY DUTIES AND RESPONSIBILITES:

• Formulation Development Leadership: Lead the design, development, and optimization of complex pharmaceutical formulations, ensuring they meet project objectives and regulatory requirements.
• Project Management: Oversee multiple formulation development projects, managing timelines, resources, and budgets. Ensure projects are completed on time and within scope.
• Technology Transfer: Manage technology transfer activities from R&D to manufacturing, ensuring seamless transition and scalability of processes.
• Experimental Design and Execution: Design and execute complex experiments to support formulation development, process optimization, and troubleshooting.
• Analyze and interpret data to draw meaningful conclusions.
• Technical Documentation: Prepare and review comprehensive technical documents, including formulation development reports, batch records, technology transfer documents, and regulatory submission documents.
• Collaboration: Work closely with cross-functional teams, including Analytical Development, Quality Assurance, Quality Control Regulatory Affairs, Manufacturing, Engineering and Supply chain to drive project success.
• Compliance and Quality: Ensure all laboratory activities comply with regulatory guidelines, Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), internal quality standards and safety policies.
• Innovation and Continuous Improvement: Stay abreast of industry trends, scientific advancements, and technological innovations to drive continuous improvement in formulation development practices.
• Mentorship: Mentor and guide junior scientists, fostering a collaborative and innovative work environment.

Education:

• Scientist: Master’s or Ph.D. in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or related field.

Experience:

• Senior Scientist: 5 to 8 years of experience in pharmaceutical formulation development, including project management and technology transfer.
• Hands-on experience with formulation and process development for various dosage forms (e.g., tablets, capsules, injectables, topical formulations).
• Proficiency in analytical techniques such as HPLC, GC, spectroscopy, and microscopy.
• Familiarity with regulatory guidelines (e.g., FDA, EMA) and quality systems (e.g.,GLP, GMP).

Preferred Qualifications:

• Experience with advanced drug delivery systems (e.g.nanoparticles, liposomes).
• Knowledge of statistical tools and software for experimental design and data analysis (e.g.Design of Experiments (DOE), Minitab, JMP).
• Previous experience in preparing regulatory submission documents (e.g. IND, NDA, ANDA).

Job Description & Requirements:

• Develop and optimize analytical methods for the characterization of pharmaceutical raw materials, intermediates, and finished products.
• Conduct method validation studies in accordance with regulatory guidelines and internal procedures.
• Perform routine and non-routine analysis of samples using various analytical techniques (e.g., HPLC, GC, UV-Vis, FTIR, dissolution testing).
• Prepare and review technical documents, including method development reports, validation protocols, standard operating procedures (SOPs), and regulatory submission documents.
• Ensure all laboratory activities comply with Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), and relevant regulatory requirements.
• Identify and resolve technical issues related to analytical methods and instrumentation.
• Analyze and interpret analytical data, ensuring accuracy and reliability of results. Prepare detailed reports and presentations of findings.
• Work closely with cross-functional teams, including Formulation Development, Quality Assurance, Quality Control, Regulatory Affairs, Manufacturing, Engineering and Supply chain to support product development and commercialization.
• Maintain laboratory equipment and instrumentation, ensuring they are in good working order. Follow all safety protocols and maintain a clean and organized laboratory environment.
• Stay current with industry trends, scientific advancements, and technological innovations to continuously improve analytical methods and practices.
• Any other duties as assigned by supervisor.

Qualifications and Education:

• Master’s or Ph.D. or Bachelor in Chemistry, Pharmaceutical Sciences, Analytical Chemistry, or related field.

Experience:

• 2 - 5 years of experience in analytical method development in the pharmaceutical industry or related field.

Key Responsibilities:**

- **Analytical Method Development:** Develop and optimize analytical methods for the characterization of pharmaceutical raw materials, intermediates, and finished products.

- **Method Validation:** Conduct method validation studies in accordance with regulatory guidelines and internal procedures.

- **Sample Analysis:** Perform routine and non-routine analysis of samples using various analytical techniques (e.g., HPLC, GC, UV-Vis, FTIR, dissolution testing).

- **Documentation:** Prepare and review technical documents, including method development reports, validation protocols, standard operating procedures (SOPs), and regulatory submission documents.

- **Compliance:** Ensure all laboratory activities comply with Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), and relevant regulatory requirements.

- **Troubleshooting:** Identify and resolve technical issues related to analytical methods and instrumentation.

- **Data Interpretation:** Analyze and interpret analytical data, ensuring accuracy and reliability of results. Prepare detailed reports and presentations of findings.

- **Collaboration:** Work closely with cross-functional teams, including Formulation Development, Quality Assurance, Quality Control, Regulatory Affairs, Manufacturing, Engineering and Supply chain to support product development and commercialization.

- **Laboratory Maintenance:** Maintain laboratory equipment and instrumentation, ensuring they are in good working order. Follow all safety protocols and maintain a clean and organized laboratory environment.

- **Continuous Improvement:** Stay current with industry trends, scientific advancements, and technological innovations to continuously improve analytical methods and practices.

· Any other duties as assigned by supervisor.

#### **Qualifications:**

- **Education:**

- Associate Scientist: Bachelor’s degree in Chemistry, Pharmaceutical Sciences, Analytical Chemistry, or related field.

- Scientist: Master’s or Ph.D. in Chemistry, Pharmaceutical Sciences, Analytical Chemistry, or related field.

- **Experience:**

- Associate Scientist: 2+ years of experience in analytical method development in the pharmaceutical industry or related field. Fresh graduate will be considered.

- Scientist: 2 - 5 years of experience in analytical method development in the pharmaceutical industry or related field.