Perform and review analysis of raw materials, intermediates, finished products, in-process, stability, water, and cleaning validation samples as per approved specifications and test methods. Operate, troubleshoot, and maintain analytical instruments including HPLC, GC, UV-Visible Spectrophotometer, FTIR, Karl Fischer Titrator, TOC Analyzer, and Dissolution Tester (where applicable). Prepare, standardize, and maintain reagents, volumetric solutions, reference standards, and working standards. Review analytical data, chromatograms, calculations, and laboratory documentation for compliance with Good Laboratory Practices (GLP) and Data Integrity (ALCOA+) principles. Investigate Out of Specification (OOS), Out of Trend (OOT), laboratory deviations, and implement Corrective and Preventive Actions (CAPA). Support analytical method validation, method verification, method transfer, and stability studies. Ensure timely calibration, qualification, and preventive maintenance of laboratory instruments. Maintain laboratory records, logbooks, electronic data, and documentation in compliance with regulatory requirements. Coordinate with QA, Production, Warehouse, and Engineering for timely sample analysis and batch release. Support internal audits, customer audits, and regulatory inspections (USFDA, MHRA, EU GMP, WHO GMP). Monitor laboratory inventory of chemicals, reagents, columns, standards, and consumables. Mentor and train QC Officers and Analysts on analytical techniques, laboratory practices, and GMP compliance. Implement 5S and continuous improvement initiatives within the laboratory.
