Assistant Manager Quality Assurance Qualification & Validation

Role & responsibilities

Qualification Activities

• Prepare, review, approve, and execute qualification protocols and reports for:
• Design Qualification (DQ)
• Installation Qualification (IQ)
• Operational Qualification (OQ)
• Performance Qualification (PQ)
• 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.