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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