Quality Assurance Manager

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, and sample flow drawings.
• Review of batch records.
• Develop and maintain quality agreements with contract manufacturers, suppliers, and laboratories.
• Write and revise GXP documents by collaboration with other departments such as quality manuals, master plans, sops, working instructions, forms, checklists, protocols, reports, masterbatch records, etc.
• Prepare, control, gather, and archive all the quality assurance-related standard operating procedures and documents.
• Ensure incoming materials, in-process, and all finished products meet specified requirements.

Requirements:

• 3 years of experience in a similar position.
• Experience in the pharmaceutical industry.
• Working knowledge of relevant FDA, EU, ICH, and PICs guidelines and regulations.
• Familiar with risk management methods.
• Ph.D. in Pharmacy.