Key Responsibilities:
- Prepare, review, and execute validation protocols and reports (IQ/OQ/PQ).
- Handle process validation, cleaning validation, and equipment qualification.
- Support utility validation (HVAC, water systems, compressed air, etc.).
- Ensure validation activities comply with GMP and regulatory guidelines.
- Review validation data and ensure proper documentation and traceability.
- Coordinate with Production, QC, Engineering, and other departments.
- Participate in risk assessments and validation planning.
- Handle deviations, change controls, and CAPA related to validation.
- Maintain validation master plan (VMP) and related documents.
- Support internal audits and regulatory inspections (USFDA, WHO, EU GMP).
