Manager, Quality – Sterile Operations

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.

Essential Functions:

+ 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 ...