Job Description

• Process Validation
  • Plan, execute, and document Process Validation (PV), Cleaning Validation (CV), and Re-validation for injectable products.
  • Prepare and review validation protocols and reports (IQ, OQ, PQ).
• Equipment & Utility Validation
  • Perform validation of:
    • Autoclaves, depyrogenation tunnels, sterilizers
    • Vial washing machines, filling lines, lyophilizers
    • Utilities: WFI, Pure Steam, HVAC, compressed air
  • Ensure calibration and qualification of critical instruments.
• Aseptic Process Validation
  • Execute and evaluate Media Fill (Aseptic Process Simulation) studies.
  • Ensure sterility assurance and contamination control compliance.
• Cleaning Validation
  • Develop cleaning validation strategies for:
    • Product changeover
    • Worst-case product selection
  • Conduct swab and rinse sampling.
• Documentation & Compliance
  • Prepare and maintain:
    • Validation Master Plan (VMP)
    • Risk assessments (FMEA, QRM)
    • SOPs related to validation
  • Ensure compliance with cGMP, WHO, USFDA, EU-GMP requirements.
• Deviation & CAPA Management
  • Investigate validation deviations and implement CAPA.
  • Participate in change control and impact assessments.
• Audit Support
  • Support regulatory audits and customer audits.
  • Present validation documents to inspectors.
• Coordination
  • Work with Production, QC, Engineering, and QA for validation activities.

  • Train manufacturing personnel on validation-related SOPs

Skill Set Required

• Process Validation - Proficient
• Cleaning Validation - Proficient
• Equipment Qualification -Proficient
• Aseptic processing and sterile manufacturing - Proficient
• Autoclave validation - Proficient
• HVAC validation - Proficient
• Media fill validation -Proficient
• Lyophilizer qualification - Proficient
• WFI system qualification -Proficiency
• Annex 1 (EU-GMP) - Advanced
• USFDA, WHO, PIC/S guidelines - Advanced
• ALCOA+ data integrity principles - Advanced
• Sampling techniques (swab & rinse).- Advanced
• Risk assessment tools: FMEA, HACCP, QRM -Advanced

Education: B.Pharm/M.Pharm

Total Experience: 4 - 6 Years

Note: Candidates who want to apply for internal jobs, must have completed at least 2 years within existing role.