● 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 a collaboration of other departments such as quality manual, 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.
● 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.