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
-Write, review and approve GMP documentation (SOPs, protocols, technical reports, technology transfer protocols, specifications, summary reports to support GMP production, change controls)
-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
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
