Key Responsibilities

• Lead the IPQA team and oversee in-process quality assurance activities across production (OSD / Injectable / Sterile / Packaging as applicable).
• Ensure line clearance is performed and documented before and after manufacturing and packaging operations.
• Monitor critical process parameters and in-process controls to ensure compliance with approved BMR/BPR and SOPs.
• Review and approve batch manufacturing and packing records, logbooks, and related GMP documentation.
• Ensure compliance with cGMP, GDP, ALCOA+ principles, and regulatory requirements (USFDA, EU GMP, WHO, MHRA).
• Coordinate with Production, QC, Engineering, Warehouse, and Validation teams for smooth manufacturing operations.
• Lead deviation investigations, root cause analysis, and CAPA implementation related to IPQA observations.
• Ensure timely escalation of critical quality issues and recommend appropriate corrective actions.
• Conduct GMP audits, floor walkthroughs, and ensure audit readiness of manufacturing areas.
• Review change controls, validation protocols, and qualification activities impacting production quality.
• Ensure data integrity compliance across production and quality systems.
• Train and mentor IPQA executives and officers on GMP compliance and quality standards.
• Participate in regulatory inspections, customer audits, and internal quality audits.
• Drive continuous improvement initiatives in quality systems and manufacturing compliance.
• Prepare and review quality metrics, trend analysis, and management review reports.