AM QA- Process Validation

2 days ago


Indore, Madhya Pradesh, India HR Services Full time ₹ 2,00,000 - ₹ 6,00,000 per year

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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