- 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 site's 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.