Quality Assurance Chief

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), and Material, Personnel, Waste, and Sample flow drawings. ● Write, review, and approve GMP documentation (SOPs, protocols, technical reports, technology transfer protocols, specifications, summary reports to support GMP production, and 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 or 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, and 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.