{"@context":"https://schema.org","@type":"JobPosting","title":"Manager, IPQA (Sterile Injectable)","description":"

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 strong quality culture.

Preferred candidate profile

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