Job Description
• Write, review and approve GMP documentation for MOH (Ministry of Health) such as SMF (Site Master File), Quality Manual, CTD (Common Technical Document), Material/Personnel/Waste/Sample flow drawings, etc.
• Write, review and approve GMP documentation (SOPs, protocols, technical reports, technology transfer protocols, specifications, summary reports to support GMP production, change controls, etc.).
• Review batch records, associated testing records, and other documentation to ensure that all steps have been executed correctly, verified where applicable, and that all limits and specifications have been met.
• Develop and maintain Quality Agreements with contract manufacturers, suppliers, and laboratories.
• Review and approve Validation Protocols and reports to ensure compliance. • Support Annual Product Review report generation and approval. • Review protocols, analytical results, and documents associated with investigations, OOS results, etc., and corrective/preventive action plans.
• Support disposition of API and finished drug product batches.
• Review stability protocols and reports.
• Collaborate with Manufacturing and lead investigation teams to resolve equipment and process related deviations.
• Conduct internal audits, track progress, and trend results.
• Participate in relevant supplier audits as needed. • Generate targeted metrics for Management Review.
• Review relevant sections of regulatory filings.
• Provide guidance on GMP manufacturing from Phase I to Commercial.
• Length of probation period: 2 Months.
• Working hours: 7:30 to 16:45 Saturday to Wednesday.
