Description

Perform analysis of API, intermediates, raw materials, solvents, and finished products using HPLC, GC, UV, and other analytical techniques. Execute routine and non-routine analysis as per approved STPs, specifications, pharmacopoeial methods, and validated analytical methods. Operate, calibrate, and maintain HPLC, GC, UV-Visible spectrophotometer, pH meter, KF, and other QC instruments. Perform assay, related substances/impurities, residual solvents, purity, water content, and other required analytical tests. Review chromatograms, analytical data, calculations, and laboratory records for accuracy and completeness. Ensure proper handling, labeling, storage, and traceability of samples, standards, reagents, and solutions. Prepare and maintain analytical worksheets, logbooks, COAs, raw data, and other QC documentation. Investigate OOS, OOT, atypical results, deviations, and analytical incidents in accordance with SOPs. Support method validation, method verification, method transfer,



and analytical method development activities. Perform instrument troubleshooting and coordinate with engineering/service teams for instrument breakdowns and preventive maintenance. Ensure timely completion of testing and reporting in accordance with production and release requirements. Follow cGMP, GLP, data integrity (ALCOA+), safety, and company quality-system requirements. Participate in internal, customer, and regulatory audits and provide required QC documentation and responses. Train junior QC analysts on analytical procedures, instrument operation, safety, and GMP practices. Coordinate with Production, QA, R&D;, Warehouse, and other cross-functional departments for QC-related activities. Ensure laboratory housekeeping, chemical safety, waste disposal, and compliance with laboratory SOPs.

📌 Senior Executive (India)
🏢 Cadila Pharmaceuticals
📍 India