Executive - Validation & Qualification QA

Lead the development, execution, and documentation of qualification protocols (DQ, IQ, OQ, PQ) for equipment, utilities, and facilities. Coordinate qualification activities across Engineering, Production, QA, and other cross‑functional teams. Maintain qualification documentation, including risk assessments and change‑control records, and ensure compliance with USFDA, MHRA, WHO GMP, and ICH Q9/Q10 standards. Support internal and external audits and inspections focused on qualification processes.

• Develop, execute, and document qualification protocols (DQ/IQ/OQ/PQ) for equipment, utilities, and facilities
• Collaborate with Engineering, Production, QA, and other cross‑functional teams to coordinate qualification activities
• Maintain qualification documentation, including risk/impact assessments and change‑control records
• Ensure compliance with USFDA, MHRA, WHOGMP, and ICH Q9/Q10 standards
• Support internal and external audits and inspections focused on qualification