- Coordinate qualification activities for manufacturing, packaging, and laboratory equipment.
- Perform periodic review and requalification of equipment and systems.
- Ensure qualification activities comply with approved Validation Master Plan (VMP).
Validation Activities
- Prepare, review, and approve validation protocols and reports for:
- Process Validation
- Cleaning Validation
- Hold Time Validation
- Filter Validation
- Aseptic Process Simulation (Media Fill)
- Sterilization Validation (Autoclave, Dry Heat Sterilizer, Depyrogenation Tunnel)
- HVAC Validation
- Water System Validation (PW/WFI)
- Compressed Air and Clean Gas Validation
- Environmental Monitoring Qualification
- Coordinate validation studies with Production, Engineering, QC, and Microbiology teams.
- Review validation data and ensure timely completion of reports.
Preferred candidate profile
- 1016 years of experience in Quality Assurance within a sterile injectable pharmaceutical manufacturing facility.
- Minimum 5 years of hands-on experience in qualification and validation profile.
Educational Qualification
- Bachelor's or Master's degree in Pharmacy (B.Pharm/M.Pharm), Pharmaceutical Sciences, Biotechnology, Microbiology, Chemical Engineering, or a related discipline.