Description

Job Purpose To perform and document analytical testing of raw materials, intermediates, APIs, in-process and finished products in accordance with approved specifications, analytical methods, SOPs, GMP and data-integrity requirements. Key Responsibilities Perform routine analysis of raw materials, intermediates, APIs, finished products and stability samples. Operate and handle analytical instruments such as HPLC, GC, UV-Visible Spectrophotometer, FTIR, Karl Fischer, pH meter and other laboratory equipment. Perform testing for assay, related substances, impurities, residual solvents, water content, identification and other specified quality parameters. Prepare mobile phases, diluents, reagents, standard and sample solutions accurately. Perform system suitability tests and ensure analytical results meet established acceptance criteria. Review chromatograms, calculations, raw data and analytical worksheets for completeness and accuracy. Carry out routine troubleshooting of HPLC and GC and coordinate with seniors/vendors for major instrument issues. Perform sampling and analysis as per approved sampling plans and specifications. Support OOS, OOT,



deviation and analytical investigation activities. Assist in method validation, method verification, method transfer and analytical method development activities. Perform stability testing as per approved stability protocols and schedules. Maintain instrument logbooks, calibration records, analytical worksheets and laboratory records. Ensure proper calibration and preventive maintenance of QC instruments. Follow GMP, GLP, SOPs and ALCOA+ data-integrity principles. Maintain proper housekeeping and ensure protected handling and disposal of chemicals and laboratory waste. Coordinate with QA, Production and other departments for timely completion of testing. Participate in internal audits, regulatory inspections and laboratory compliance activities when required. Qualification B.Sc./M.Sc. Chemistry, B.Pharm/M.Pharm or equivalent qualification. Relevant experience in pharmaceutical/API quality control preferred. Experience 1–4 years of relevant experience in API / pharmaceutical QC, preferably with hands-on HPLC and GC experience.

📌 Officer Mumbai
🏢 Cadila Pharmaceuticals
📍 Mumbai