QA MANAGER

Job Description : QA MANAGER (BIOLOGICS) ???? ???? Location: Myanmar ???? Industry: Pharmaceutical – Biologics Manufacturing ???? Salary: Up to ?2.5 Lakh/Month ???? Experience: 12+ Years ? Eligibility Criteria: • Biologics manufacturing plant experience is mandatory. • Hands-on exposure to PFS (Pre-Filled Syringes), Monoclonal Antibodies (MAbs), and Vial manufacturing operations. • Strong knowledge of Quality Management Systems (QMS), GMP, Data Integrity, Risk Management, and Regulatory Compliance. • Experience handling international regulatory audits and inspections. ???? Company Benefits: ? Air Ticket ? Visa ? Accommodation ???? Key Responsibilities: • Lead and manage overall Quality Assurance activities across biologics manufacturing operations. • Ensure compliance with cGMP, WHO, USFDA, EU GMP, MHRA, and other regulatory requirements. • Oversee Batch Record Review, Product Release, Change Control, Deviations, CAPA, OOS, OOT, and Risk Assessments. • Manage QA oversight for PFS, MAbs, and Vial manufacturing processes. • Review and approve qualification, validation, SOPs, protocols, reports, and quality documentation. • Ensure implementation and maintenance of Quality Management Systems (QMS). • Lead internal audits, vendor audits, and regulatory inspections. • Drive continuous quality improvement initiatives and compliance culture. • Monitor Data Integrity practices and ensure adherence across manufacturing and quality systems. • Coordinate with Production, QC, Engineering, Validation, and Regulatory Affairs teams. • Provide leadership, mentoring, and training to QA personnel

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