Summary:
The incumbent will support the Quality Systems team in establishing, maintaining, and continuously improving an effective Quality Management System (QMS). This role focuses primarily on GMP document control and training management to ensure operational efficiency, regulatory compliance, and seamless system execution.
Responsibilities:
GMP Documentation Management
Serve as QA Document Coordinator and support the full lifecycle management of GMP documentation-including creation, revision, review, issuance, retirement, archiving, and destruction-ensuring accuracy, traceability, and compliance. Responsibilities include:
- Setting document effective dates.
- Creating and launching exams/trainings associated with documents.
- Printing and issuing controlled documents, forms, and logbooks to relevant functions, ensuring proper reconciliation and tracking.
- Supporting archival management of both electronic and paper-based records.
Training Management
Serve as QA Training Coordinator, supporting employee training activities and compliance with GMP training requirements:
Assist in planning and coordinating annual GMP training.
- Maintain and manage QA training records.
- Extract and report training-related metrics (e.g., overdue training, upcoming deadlines).
- Support New Employee Orientation (NEO) for QA-related training components.
Quality System Maintenance
- Assist in establishing and maintaining an effective quality system aligned with current regulatory requirements.
- Support periodic review and revision of GMP documents as needed.
Administrative & Quality Support
- Compile and continuously update live documents such as the Qualified Supplier List to ensure accuracy and availability.
- Extract data and support routine reviews of key quality metrics for continuous improvement, including trend analysis for deviations, CAPAs, change controls, complaints, etc.
- Coordinate and arrange regular Quality Management Review (QMR) meetings.
Quality Culture and Data Integrity Initiatives
- Organise and support site-wide activities and events that promote Quality Culture and Data Integrity across the organisation.
Other Duties
- Perform additional tasks or assignments as assigned by the Supervisor.
About You:
- Bachelor degree or above in Chemistry, Biochemistry, Biology, Pharmaceutical. Biological Engineering, or related field.
- At least 1 - 2 years prior experience in pharmaceutical manufacturing and/or quality management or QA preferably those with biopharma commercial quality systems.
- Familiar with FDA, EMEA, HSA and PIC/S GMP requirements.
- Added advantages for those with setting up quality systems for new sites experiences.
- Skilled in Microsoft Word, Excel, PowerPoint, MasterControl, TrackWise, SAP.
- Good communication and teamwork skills.
Duration: 6 months
Office hours
