Position Overview The QA Validation professional provides quality oversight, review, and approval of validation and qualification activities to ensure compliance with GMP, regulatory expectations, and internal quality systems. This role ensures that validation deliverables are scientifically sound, risk‑based, and inspection‑ready, while supporting cross‑functional project execution in a GMP‑regulated environment.
Key Responsibilities - Provide QA oversight for equipment, facility, utility, process, and cleaning validation and qualification activities
- Ensure validation approaches align with GMP, data integrity principles, and regulatory guidelines (e.g., FDA, EMA, PIC/S)
- Review validation strategies to ensure compliant, risk‑based execution
- Review and approve validation lifecycle documentation, including:
- Validation Master Plan (VMP)
- Risk assessments (e.g., FMEA, SRA)
- URS, DQ, IQ, OQ, PQ
- Clean...