Description

Perform routine analysis of API, intermediates, raw materials and finished products as per approved analytical methods and specifications. Execute analysis using HPLC, GC, UV, FTIR, Karl Fischer, pH meter and other laboratory instruments. Perform testing for assay, related substances, impurities, residual solvents, water content, identification and other quality parameters. Prepare and standardize solutions, reagents, mobile phases, diluents and analytical standards. Perform system suitability testing and ensure validity of analytical results. Review chromatograms, analytical calculations, raw data and laboratory records for accuracy and completeness. Identify and troubleshoot HPLC/GC-related issues such as abnormal peaks, poor resolution, pressure variation, carryover and system suitability failures. Handle and support investigations related to OOS, OOT, deviations and analytical discrepancies. Support method validation, method verification, method transfer and analytical method development activities. Perform stability sample analysis and maintain stability-related documentation. Ensure proper operation, calibration and preventive maintenance of laboratory instruments. Maintain laboratory notebooks, instrument logbooks, worksheets, SOPs and other GMP documentation.



Ensure compliance with GMP, GLP, SOPs, ALCOA+ and data-integrity requirements. Coordinate with QA, Production, R&D; and other departments for timely completion of analytical activities. Train junior QC officers/analysts on analytical procedures, instruments and laboratory practices. Ensure proper housekeeping, chemical handling, waste disposal and safety practices in the laboratory. Required Qualifications B.Sc./M.Sc. Chemistry, B.Pharm/M.Pharm or equivalent qualification. Relevant experience in API pharmaceutical QC. Strong hands-on experience in HPLC and GC. Positive understanding of pharmaceutical analytical techniques, specifications and GMP documentation. Key Competencies HPLC & GC operation and troubleshooting API and intermediate analysis Impurity/related-substance analysis OOS/OOT investigation GMP/GLP and data integrity Analytical documentation Instrument calibration and maintenance Problem-solving and analytical thinking Team coordination and training Experience Typically 2–5 years of relevant experience in API Quality Control, preferably with hands-on experience in HPLC, GC and routine API/intermediate analysis.

📌 Junior Officer (India)
🏢 Cadila Pharmaceuticals
📍 India