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Job Positions:

  • Officer / Sr. Officer
  • Executive / Sr. Executive
  • Assistant Manager

Department:

  • Quality Assurance

Required Qualifications:

  • B.Sc / M.Sc
  • B.Pharm / M.Pharm
  • BE Chem

Experience:

  • 2 to 15 years (Candidates must have relevant experience in API Pharma)

Location:

  • Valia Unit

Key Responsibilities:

  1. Perform equipment and utility qualification activities with comprehensive documentation.
  2. Conduct computer system validation.
  3. Investigate deviations, change requests, out-of-specifications (OOS), and market complaints.
  4. Review and close deviations, change control, corrective and preventive actions (CAPA), and OOS investigations.
  5. Prepare and review quality risk assessment reports.
  6. Develop and review process validation and cleaning validation protocols and reports.
  7. Conduct QC instrument qualification and calibration.
  8. Review analytical and raw data from method validation and transfers.
  9. Manage and investigate out-of-control (OOC) and out-of-trend (OOT) results.
  10. Monitor and control records for stability chambers and retain samples.
  11. Participate in digital initiatives, training, and regulatory support.
  12. Update Drug Master Files (DMF) as required by the regulatory department.
  13. Review and close global CAPA.
  14. Perform in-process quality assurance (IPQA) activities.
  15. Support QA digitalization efforts.
  16. Manage documentation and QA release activities.

Application Process:

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