Assistant Manager IPQA

Role & responsibilities

• Handle IPQA activities for OSD manufacturing and packing operations.
• Perform in-process checks and line clearance as per approved SOPs/BMR/BPR.
• Review BMR/BPR, logbooks, checklists and other GMP documents.
• Monitor manufacturing processes and ensure compliance with cGMP, SOPs and regulatory requirements.
• Handle deviations, OOS/OOT, CAPA and change control related to production activities.
• Ensure compliance with data integrity and documentation practices.
• Coordinate with Production, QC, QA and Engineering departments for timely resolution of quality issues.
• Support internal, customer and regulatory audits, including USFDA inspections.
• Ensure proper implementation of GMP and QMS requirements on the shop floor.
• Review and approve cleaning, environmental and process-related records as applicable.

Preferred candidate profile

Candidates from OSD formulation plants with exposure to USFDA-approved facilities / regulatory audits preferred.