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)