
Responsible for QC analysis including HPLC, GC, LCMS and other routine instruments. Perform assay, dissolution, raw material and finished product testing, stability studies, OOS/OOT handling, and laboratory deviation investigations. Ensure compliance with GLP, cGMP, 21 CFR, and regulatory requirements (USFDA/EU). Involved in analytical method validation/transfer, instrument calibration, and documentation review as per pharmacopeial standards.