Commercial Quality Manager
1 week ago
- Job Summary:
- The Commercial Quality Specialist is responsible for providing independent support in the affiliate, encompassing quality system requirements for pharmaceutical products, medical devices, combination products, biologics, and cosmetics.
- This role involves integration of local quality regulations, design of effective quality systems, assessments for compliance, planning, and approval of quality documentation.
- The Specialist will also coordinate internal, external, and MoH audits, investigate quality events, execute supplier qualification programs, and monitor metrics and KPIs for compliance.
- Key Responsibilities:
- Represent Commercial Quality in cross-functional teams, projects, and programs as assigned by management.
- Requirements:
- Bachelor's Degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering, or other technical/scientific area preferred.
- 3+ years experience in quality assurance, GMP, or GDP environment preferred.
- Strong computer skills, familiarity with SAP, TrackWise, ComplianceWire, and OneVault required.
- Fully understand local GxP requirements including regulations and standards affecting device, biologics, pharmaceutical products, and cosmetics.
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