Description

Perform analysis of API, intermediates, raw materials, in-process and finished products as per approved specifications and SOPs. Handle and troubleshoot HPLC and GC instruments for routine and stability analysis. Perform analytical testing such as assay, related substances/impurities, residual solvents, water content, identification and purity. Operate and maintain laboratory instruments including HPLC, GC, UV, IR, Karl Fischer, pH meter, etc. Prepare mobile phases, diluents, standards and reagents accurately. Review analytical results, chromatograms, calculations and laboratory records. Ensure compliance with GMP, GLP, SOPs and data-integrity requirements. Perform instrument calibration, system suitability and routine maintenance activities. Investigate OOS/OOT results, deviations and analytical discrepancies. Assist in method validation/verification, method transfer and analytical method development activities. Maintain laboratory documentation, logbooks,



worksheets and analytical records. Coordinate with Production, QA and other departments for timely completion of testing. Ensure safe handling, storage and disposal of chemicals and laboratory samples. Key Skills Strong hands-on experience in HPLC and GC. Good knowledge of chromatographic troubleshooting. Understanding of API pharmaceutical analysis and impurity profiling. Knowledge of GMP/GLP, OOS, OOT, deviation and CAPA. Positive documentation and analytical calculation skills. Ability to interpret chromatograms and investigate abnormal results. Experience with instruments such as Agilent / Shimadzu / Waters HPLC and GC is desirable. Preferred Experience API manufacturing / pharmaceutical QC experience with strong HPLC & GC exposure, particularly in routine analysis, stability testing and OOS/OOT investigation.

📌 Senior Officer (India)
🏢 Cadila Pharmaceuticals
📍 India