Job Description
Key Responsibilities:
- Prepare and execute validation protocols (IQ, OQ, PQ) for equipment, facilities, and utilities.
- Conduct cleaning validation and revalidation studies, including swab/rinse sampling and microbial testing coordination.
- Perform process validation (PV) activities for new and existing products.
- Coordinate with cross-functional teams (Production, QC, Engineering, R&D) for validation execution and troubleshooting.
- Review and update validation master plans (VMP), protocols, and reports as per regulatory requirements.
- Ensure calibration and qualification records are up to date and compliant.
- Maintain documentation in compliance with data integrity and ALCOA+ principles.
- Support audits and regulatory inspections by providing validation documentation and clarifications.
- Track and monitor validation schedules and ensure timely completion.
- Stay updated with latest regulatory...
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