مدیر تضمین کیفیت

گروه درمان ياب

کرج

منتشر شده 1 ماه پیش

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 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.

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.

Employment Type

  • Full Time

Seniority

Employment type

  • Full Time

Seniority

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