Posted:Just now|
Platform:
Work from Office
Full Time
Key Responsibilities: Perform analysis of raw materials, intermediates, and finished products of Active Pharmaceutical Ingredients (APIs) as per approved specifications and SOPs. Operate and maintain analytical instruments like HPLC, GC, UV-Vis Spectrophotometer, FTIR, Karl Fischer, Melting Point Apparatus, etc. Review and verify analytical data and ensure proper documentation in line with cGMP and GLP guidelines. Prepare and standardize volumetric solutions and reagents. Carry out stability studies and maintain stability data as per ICH guidelines. Ensure timely calibration of laboratory instruments. Perform method validation/transfer activities as per regulatory and internal requirements. Involve in investigations related to OOS/OOT/Deviations and CAPA implementation. Coordinate with cross-functional departments like QA, Production, and R&D for smooth workflow. Comply with all safety protocols and maintain a clean and organized lab environment. Desired Candidate Profile: Hands-on experience in analytical techniques (HPLC/GC) is a must. Good knowledge of regulatory guidelines (ICH, WHO, USFDA, etc.) Strong documentation and communication skills. Experience in a regulated API manufacturing unit is preferred.
MSN Group
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