Manager, Quality – Sterile Operations

Job description

Description: The Sterile BFS QA/QM Manager is responsible for leading all Quality Assurance (QA) and Quality Management (QM) functions within a sterile Blow-Fill-Seal (BFS) manufacturing environment. The manager will oversee quality operations, drive continuous improvement initiatives, manage internal and external audits, and ensure a state of inspection readiness. Education: Experience: - Design, review, and approve protocols for media fills to validate that the BFS or bag-filling process consistently produces sterile products. Provide quality oversight for validation lifecycle activities, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for BFS machines and bag-filling lines. Monitor the Grade A environment, clean utility systems (WFI, clean steam), and ensure proper sterilization cycles (CIP/SIP) for the equipment. Analyze EM data for cleanrooms and surrounding areas, ensuring microbial counts are within limits. Review batch records, manufacturing, and packaging documentation for compliance with cGMP to ensure product safety. Evaluate the impact of proposed changes to manufacturing equipment, processes, or materials. L...