Job Purpose

To ensure cGMP and regulatory compliance through effective in-process quality assurance across sterile injectable manufacturing operations, ensuring product quality, data integrity, and inspection readiness.

Key Responsibilities

- Ensure cGMP compliance during dispensing, compounding, filling, visual inspection, packing, and warehouse operations.
- Perform line clearance, in-process checks, and real-time shopfloor monitoring.
- Review BMRs, BPRs, logbooks, and GMP documentation for compliance and completeness.
- Monitor aseptic practices, cleanroom behavior, and sterility assurance activities.
- Review and support investigations related to deviations, OOS, OOT, change controls, and CAPA.
- Ensure compliance with SOPs, validation protocols, and regulatory requirements.
- Support process validation, media fills, equipment qualification, and technology transfer activities.
- Participate in internal, customer, and regulatory audits and ensure timely closure of observations.
- Drive GMP awareness through training and cross-functional coordination.
- Lead and develop the IPQA team while promoting a robust quality culture.

Preferred candidate profile

📌 Manager, IPQA (Sterile Injectable) (Nalagarh)
🏢 Immacule Life Sciences
📍 Nalagarh