- Develop, execute, and review validation protocols (IQ, OQ, PQ) for equipment, utilities, and processes.
- Conduct risk assessments and ensure compliance with GMP, FDA, and other regulatory requirements.
- Coordinate process validation, cleaning validation, and computer system validation activities.
- Ensure timely qualification and requalification of manufacturing equipment and systems.
- Investigate validation deviations and provide corrective and preventive actions (CAPA).
- Collaborate with cross-functional teams, including production, R&D, and regulatory affairs.
- Maintain and update validation documentation, reports, and records.
- Assist in regulatory inspections and internal/external audits.
Bachelor’s degree in Pharmacy, Chemistry, Biotechnology, or a related field.Minimum of 5 years of experience in QA validation within the pharmaceutical industry.Strong knowledge of GMP, FDA, EMA, and other regulatory requirements.Experience in equipment, process, and cleaning validation.Excellent analytical, problem-solving, and communication skills.Ability to manage multiple projects and meet strict deadlines.