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Process Qualification Manager
vor 1 Woche
About the Role
This senior-level position is accountable for leading a team responsible for the commissioning and qualification of process systems within a biopharma or pharmaceutical manufacturing environment. The ideal candidate will possess strong technical knowledge, excellent leadership skills, and experience in managing cross-functional teams.
Main Responsibilities and Tasks:
- CQV Planning and Preparation: Developing a comprehensive level 3 CQ plan, defining workflows and approval cycles for CQ test plans and specifications, and coordinating development and approvals.
- CQV Execution and Testing: Ensuring daily multidisciplinary CQV, Eng, CM, and USER coordination meetings, HSE management, MC acceptance, and managing CQV execution activities.
- CQV Documentation and Reporting: Managing CQV related documentation, developing positive working relationships with team members and USER groups, and ensuring adherence to schedule, man-hours, and quality.
- Project Controls and Monitoring: Coordinating updates to the CQ schedule, including actualized and forecasting data, progress reporting, and invoice approval and stage payment.
