Description

Participate in customer, regulatory, and internal audits including USFDA, MHRA, WHO-GMP, EDQM, and other global regulatory inspections. Provide analytical data and laboratory documentation during inspections. Ensure audit observations are addressed within agreed timelines. Prepare and maintain analytical worksheets, logbooks, instrument usage records, and laboratory documentation. Ensure compliance with cGMP, GLP, Data Integrity (ALCOA+), and applicable regulatory requirements. Participate in Out of Specification (OOS), Out of Trend (OOT), deviation, incident investigations, and implementation of Corrective and Preventive Actions (CAPA). Review analytical data, calculations, chromatograms, and laboratory records for accuracy and compliance. Perform calibration, verification, and routine maintenance of laboratory instruments. Ensure laboratory housekeeping, safety, and compliance with Valuable Laboratory Practices (GLP). Maintain inventory of laboratory chemicals, reagents, reference standards, columns, and consumables.

📌 Senior Executive (India)
🏢 Cadila Pharmaceuticals
📍 India