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
Qualifications
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.
