Job Description
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Job Description
Mission:The QAM maintains and improves the Quality Management System (QMS), ensuring all commercialized products follow GSP and regulatory standards. A primary focus is overseeing Quality aspects of products produced by Contract Manufacturing Organizations (CMO) to ensure adherence to EU-GMP guidelines, regulatory filings, and Quality Technical Agreements.
Responsibilities
• QMS & Documentation: Establish and improve the QMS in compliance with GSP. Review batch records, SOPs, and validation protocols to ensure data integrity.
• CMO Oversight: Actively monitor third-party manufacturer performance through site visits, data reviews, and management of Quality Technical Agreements.
• Batch Release: Review and approve Batch Manufacturing Records (BMRs) and analytical data. Provide final authorization for finished product market release.
• Validation & Tec...