QA Assistant Manager (Qualification)
Job Summary
Equipment Qualification: Prepare review and approve Design Qualification (DQ) Installation Qualification (IQ) Operational Qualification (OQ) and Performance Qualification (PQ) protocols and reports for OSD equipment (e.g. Rapid Mixer Granulators Fluid Bed Dryers Compression Machines Auto-Coaters Blister & Bottle Packaging lines).
Utility & Facility Qualification: Oversee the qualification and periodic requalification of critical utilities including HVAC systems Purified Water (PW) systems Compressed Air and Nitrogen gas systems.
Validation Master Plan (VMP): Assist in the preparation execution and routine maintenance of the sites Validation Master Plan ensuring all activities adhere to the planned schedule.
FAT/SAT Execution: Review Factory Acceptance Test (FAT) and Site Acceptance Test (SAT) documents coordinating directly with the Engineering team and vendors for successful execution.
Required Experience:
Manager