Quality Systems Associate Specialist (Pharma/Biotech)

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, training management and support supplier management program. 

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.

Supplier Management

• Support in supplier qualification activities in accordance with company procedures and GMP requirements.
• Liaise with internal stakeholders (Manufacturing, Procurement, QC etc.) and suppliers to ensure timely completion of supplier questionnaires and supporting documents. Coordinate with affiliate sites personnel to obtain supplier qualification documentation for leverage opportunities.
• Support on-site audit at supplier site (when required), including audit preparation, agenda setting, audit report and coordination of CAPA responses to close of audit observations.
• Draft/Revise Quality Agreements (QAAs) with suppliers.
• Conduct quality risk assessments to determine supplier suitability for GMP use.
• Compile and continuously update live documents such as the Qualified Supplier List to ensure accuracy and availability
• Support team in periodic supplier performance monitoring, change notification and supplier decommissioning activities are performed timely.

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

• 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.
• Minimum 1–2 years of experience in biopharmaceutical manufacturing, quality management, or supplier qualification within a QA function.
• Working knowledge of GMP requirements, including FDA, EMA, HSA, and PIC/S regulations.
• Experience supporting the establishment or implementation of quality systems is an advantage.
• Familiarity with commercial biopharmaceutical quality systems is preferred.
• Competent in Microsoft Office applications (Word, Excel, PowerPoint) and quality management systems such as MasterControl, TrackWise, and SAP.
• Strong learning agility with the ability to quickly adapt to new systems and processes.
• Effective communication and collaboration skills, with the ability to work across cross-functional teams.

Duration: 6 months

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