Perform routine analysis of raw materials, intermediates, finished products, stability samples, and cleaning validation samples. Operate and maintain analytical instruments such as HPLC, GC, UV-Visible Spectrophotometer, FTIR, Karl Fischer, Dissolution Apparatus, and TOC Analyzer. Prepare analytical solutions, reagents, standards, and volumetric solutions as per approved procedures. Review analytical data, chromatograms, and laboratory records to ensure data accuracy and compliance. Execute method validation, method verification, method transfer, and analytical method development activities as assigned. Ensure compliance with ALCOA+ principles and maintain data integrity in all laboratory activities. Perform laboratory investigations related to OOS, OOT, deviations, incidents, and CAPA implementation. Support calibration, qualification, and preventive maintenance activities for laboratory instruments. Ensure proper documentation in laboratory notebooks, logbooks, worksheets, and electronic systems such as LIMS. Maintain laboratory housekeeping and adhere to EHS, GMP, GLP, and GDP requirements. Coordinate with QA, Production, Engineering, and Warehouse teams for sample management and timely release of materials. Participate in internal audits, customer audits, and regulatory inspections.
