Perform analysis of raw materials, intermediates, APIs, stability samples, and finished products using HPLC. Operate, calibrate, and maintain HPLC systems as per SOPs. Prepare mobile phases, reagents, standard solutions, and test samples. Review chromatograms and ensure compliance with analytical specifications. Perform method verification, method transfer, and analytical method validation activities. Troubleshoot HPLC-related issues and coordinate with engineering/service teams when required. Ensure compliance with ALCOA+, Data Integrity, GMP, GLP, and laboratory safety requirements. Maintain analytical records, logbooks, and laboratory documentation accurately. Support OOS, OOT, deviation, CAPA, and change control investigations. Ensure timely completion of sample analysis to support production and batch release. Participate in laboratory housekeeping, 5S, safety initiatives, and internal/external audits.
