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Validation - executive

Gujarat

Job Description

The Senior Officer – QC (Validation) will be responsible for testing and analysis of sample to ensure compliance .

  • Perform validation activities for QC instruments, equipment, and analytical methods as per regulatory guidelines (USFDA, EU, ICH).

  • Execute calibration, qualification (IQ/OQ/PQ), and periodic review of QC laboratory equipment.

  • Prepare and review validation protocols, reports, and related SOPs.

  • Ensure compliance of analytical methods with current pharmacopeia requirements (USP, EP, BP, IP).

  • Support analytical method transfer and method validation activities.

  • Participate in investigations, deviations, OOS/OOT results, and CAPA implementation related to validation.

  • Maintain documentation and records in line with cGMP and data integrity requirements.

  • Coordinate with cross-functional teams during audits and regulatory inspections.

  • Train QC staff on validation-related procedures and updates.