- Execute process validation and re-validation activities for solid oral manufacturing processes (granulation, compression, coating, blending) to confirm reproducibility and compliance with cGMP.
- Draft, review, and approve qualification and validation protocols (DQ, IQ, OQ, PQ) for OSD manufacturing equipment, packaging lines, cleanrooms, and critical utilities.
- Cleaning & Computerized Systems Validation: Verify cleaning validation procedures for equipment surfaces, alongside managing computer system validation (CSV) and data integrity compliance.
- Facilitate internal and external regulatory inspections (such as USFDA, MHRA, WHO-GMP) by maintaining updated validation master plans (VMPs), equipment logs, and calibration records.
- Investigate deviations, out-of-specification (OOS) results, or anomalies during validation runs, and implement robust Corrective and Preventive Actions (CAPA)