QA Manager

Varian Pharmed

Eshtehard

Posted a month ago

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

Requirements

-At least 5 years of experience in the pharmaceutical/biotech industry -Working knowledge of relevant FDA, EU, ICH, PICs guidelines and regulations -Experience working with CMOs, vendors, and relationship management preferred -Experience working with aseptic fermentation and oral dosage finish products -Excellent judgment and ability to communicate complex issues in an understandable way -Ability to manage multiple projects in a fast-paced environment, project management experience a plus -Ability to effectively collaborate in a dynamic, cross-functional matrix environment -Ideal Age Range: 30 - 40

Job Category

  • Quality Control, QA & Inspection

Employment type

  • Full Time

Seniority

  • Manager

Job Category

  • Quality Control, QA & Inspection

Employment type:

  • Full Time

Educations:

  • Chemistry
  • Pharmacy/Pharmacology

Seniority:

  • Manager

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