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.
