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.

📌 Assistant Manager Quality Assurance Qualification & Validation Nalagarh
🏢 Immacule Life Sciences
📍 Nalagarh