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3.0 - 7.0 years
0 Lacs
telangana
On-site
The responsibilities of this role include performing analysis of raw materials, intermediates, and finished products of Active Pharmaceutical Ingredients (APIs) according to approved specifications and Standard Operating Procedures (SOPs). You will be responsible for operating and maintaining analytical instruments such as HPLC, GC, UV-Vis Spectrophotometer, FTIR, Karl Fischer, Melting Point Apparatus, etc. Additionally, you will review and verify analytical data, ensuring proper documentation in accordance with cGMP and GLP guidelines. Preparation and standardization of volumetric solutions and reagents, carrying out stability studies as per ICH guidelines, and ensuring timely calibration of laboratory instruments are also key responsibilities. Method validation/transfer activities as per regulatory and internal requirements, participation in investigations related to OOS/OOT/Deviations and CAPA implementation, and coordination with QA, Production, and R&D departments for smooth workflow are essential tasks. Compliance with safety protocols and maintaining a clean and organized lab environment are also part of the role. The ideal candidate should have hands-on experience in analytical techniques, especially HPLC/GC. A good understanding of regulatory guidelines such as ICH, WHO, USFDA, etc., is required. Strong documentation and communication skills are essential, and experience in a regulated API manufacturing unit is preferred. This position falls under the Pharmaceutical & Life Sciences industry, specifically in the Corporate Quality Control department. It is a Full Time, Permanent role.,
Posted 2 weeks ago
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