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.