Description

Review Batch Manufacturing Records (BMRs), Batch Packaging Records (where applicable), logbooks, and supporting documents for completeness and compliance. Ensure all production activities are performed according to approved SOPs, specifications, and cGMP requirements. Verify line clearance, equipment status labels, and documentation before manufacturing activities. Ensure compliance with Valuable Documentation Practices (GDP) and data integrity requirements (ALCOA+). Perform routine shop-floor QA activities during manufacturing operations. Monitor critical manufacturing processes and verify adherence to approved process parameters. Conduct in-process checks and verify compliance with approved procedures. Review and approve cleaning and equipment status before batch initiation. Participate in investigations related to deviations, non-conformances, OOS, OOT, and customer complaints. Assist in preparing Root Cause Analysis (RCA) and implementing Corrective and Preventive Actions (CAPA). Support Change Control, Risk Assessment, and Annual Product Quality Review (APQR/PQR) activities. Maintain and update quality records and documentation.

📌 Senior Officer (India)
🏢 Cadila Pharmaceuticals
📍 India