Quality Assurance Manager
2 weeks ago
The Quality Assurance Manager will provide direct quality support to a production area as part of a Quality Integrated Product Team (IPT). With guidance from the Associate Director of Quality Operations, this role ensures quality and compliance of products manufactured by the functional area, adherence to Good Manufacturing Practices, and represents quality on the shop floor.
Key Responsibilities:
- Review and approve new and updated Master Batch Records/Electronic Batch Records for accuracy and compliance with cGMPs.
- Provide presence on the shop floor to support compliance and data integrity.
- Actively participate in the Tier process and use this forum to make issues visible and partner with the functional area on resolution.
- Support sustaining activities such as Change Management, Deviations, CAPAs, Equipment Requalification, and Periodic Review.
- Collaborate with cross-functional team members in identifying and implementing continuous improvement initiatives.
Requirements:
- Minimum 5 years of relevant post-degree work experience in GMP Manufacturing, Quality Assurance, or Laboratory environment.
- Demonstrated leadership skills, good oral and written communication skills, and understanding of cGMPs and regulatory requirements.
- Familiarity with Quality systems, pharmaceutical manufacturing processes, and authoring/approving GMP documents.
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