AM QA- Process Validation
2 days ago
Role & responsibilities
Process Validation
- Review and approve VMPs, validation protocols, and reports.
- Ensure compliance with GMP, regulatory requirements, and data integrity.
- Oversee PPQ batches, media fills, and aseptic process validation.
- Manage and approve deviations, CAPA, and change controls.
- Support audits with relevant validation documentation and justifications.
Equipment Validation
- Approve URS, DQ, IQ, OQ, PQ documents for critical sterile equipment (e.g., lyophilizers, autoclaves, HVAC, filling lines).
- Ensure risk-based validation aligned with product and equipment criticality.
- Oversee cleaning validation, calibration, and preventive maintenance programs.
- Assess validation impact during equipment changes or lifecycle transitions.
Verify compliance with 21 CFR Part 11 / Annex 11 for computerized systems
Preferred candidate profile
Must have experience in process and equipment validation.
Only looking injectable back ground candidates.
Ready to relocated to Indore location.
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