Job Description
● Review and approval CTD.
● 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, 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 disposition of API and finished drug product batches.
● Review stability protocols and reports.
