Perform analysis of Raw Materials (RM), Packing Materials (PM), Intermediates, Finished Products, Stability Samples, and Cleaning Validation samples. Operate and maintain analytical instruments such as HPLC, GC, UV-Visible Spectrophotometer, FTIR, Dissolution Apparatus, Karl Fischer, TOC Analyzer, and pH Meter. Prepare reagents, volumetric solutions, mobile phases, and standard solutions as per approved procedures. Perform instrument calibration, verification, and routine maintenance. Ensure accurate documentation in accordance with ALCOA+ principles, GDP, GLP, and cGMP requirements. Review analytical data and report any Out of Specification (OOS), Out of Trend (OOT), or laboratory deviations. Participate in OOS, OOT, deviation, CAPA, and change control investigations. Ensure timely completion of sample testing and report generation. Maintain laboratory housekeeping and 5S standards. Support method validation, method transfer, verification, and analytical troubleshooting. Participate in internal, customer, and regulatory audits including USFDA, MHRA, WHO, and other inspections.
