Description

Perform shop floor QA activities to ensure compliance with cGMP, SOPs, and approved manufacturing procedures. Review Batch Manufacturing Records (BMR), Batch Packaging Records (BPR), logbooks, and other GMP documents for completeness and accuracy. Monitor dispensing, manufacturing, packing, and cleaning activities to ensure adherence to approved procedures. Review and approve line clearance, equipment clearance, and area clearance before production activities. Participate in investigations related to deviations, incidents, OOS, OOT, complaints, and CAPA implementation. Support Change Control, Risk Assessment, and Quality Risk Management (QRM) activities. Coordinate qualification and validation activities, including process validation, cleaning validation, equipment qualification, and utility validation.



Conduct GMP audits, document reviews, and compliance inspections across production and warehouse areas. Review SOPs, specifications, protocols, reports, and other quality documents. Ensure compliance with Data Integrity (ALCOA+) requirements and Positive Documentation Practices (GDP). Support internal, customer, and regulatory audits (USFDA, MHRA, EU GMP, WHO GMP) and ensure timely closure of audit observations. Monitor environmental and GMP compliance on the shop floor. Coordinate with Production, QC, Engineering, Warehouse, and EHS to resolve quality-related issues.

📌 Officer (India)
🏢 Cadila Pharmaceuticals
📍 India