Job Purpose
JOB DESCRIPTION
To lead and manage validation activities for sterile injectable manufacturing operations, ensuring compliance with regulatory requirements (USFDA, EU GMP, WHO, MHRA, etc.), internal quality standards, and data integrity principles.
Key Responsibilities1. Validation Oversight
- Review and approve Validation Master Plan (VMP).
- Prepare, review, and approve protocols and reports for:
- Equipment Qualification (DQ, IQ, OQ, PQ)
- Process Validation (Media Fill, APS, PPQ)
- Cleaning Validation
- HVAC Validation
- Water System Validation (PW/WFI)
- Compressed Air / Nitrogen Validation
- Computer System Validation (CSV)
- Ensure lifecycle approach to validation as per regulatory expectations.
2. Sterile Injectable Compliance
- Ensure validation activities comply with:
- EU Annex 1 (Sterile Products)
- USFDA guidelines
- PIC/S, WHO requirements
- Support aseptic process simulations and contamination control strategy (CCS).
- Review environmental monitoring trends linked to validation activities.
3. Documentation & Data Integrity
- Ensure ALCOA+ principles in all validation documentation.
- Review and approve SOPs related to validation.
- Maintain validation traceability matrix.
- Ensure periodic review and requalification schedules are met.
4. Regulatory & Audit Readiness
- Face regulatory audits (USFDA, MHRA, EMA, WHO).
- Provide validation documentation during inspections.
- Address audit observations (CAPA management).
5. Cross-Functional Coordination
- Coordinate with:
- Production
- Engineering
- QC Microbiology
- QC Chemical
- Projects Team
- Provide validation input during new equipment procurement and facility modifications.
6. Risk Management
- Conduct Risk Assessments (FMEA, QRM).
- Ensure validation strategy aligns with product risk profile.
- Review change controls impacting validated state.
7. Team Management
- Supervise validation officers/executives.
- Provide technical guidance and training.
- Monitor team KPIs and ensure timely completion of validation activities.
Skills
Process Validation (PV) for sterile injectable products - Proficient
Equipment Qualification IQ, OQ, PQ - Expert
SOP preparation and review - Expert
Change Control Management -expert
Audit documentation & compliance - Expert
Cross-functional coordination (Production, Engineering, QC) - Expert
Qualifications
Education: B. Pharma / M. pharma / B.Tech / B.E
Total Experience - 10 - 12 Years
Note: Candidates who want to apply for internal jobs, must have completed at least 2 years within existing role.
