- Instrument Operation & Calibration: Routine analysis using High-Performance Liquid Chromatography (HPLC), Gas Chromatography (GC), and UV-Visible Spectrophotometers. Daily calibration and system suitability testing. [, 2, 3]
- Analysis Types: Testing of Raw Materials (RM), In-Process (IP) samples, Finished Products (FP), and stability samples. [1, 3]
- Method Validation & Transfer: Executing analytical method validation (AMV) protocols according to ICH guidelines. [1, 2]
- Compliance & Documentation: Preparing and reviewing M dossiers, deviations, OOS (Out of Specification), and OOT (Out of Trend) investigations. Ensuring strict compliance with cGMP, GLP, and international regulatory standards (USFDA, MHRA, WHO-GMP). [1, 2, 4]
- Software Proficiency: Hands-on experience with chromatography data software like Empower 3 or LabSolutions.
Core Requirements
- Education: B.Sc / M.Sc in Chemistry / Organic Chemistry, or B.Pharm / M.Pharm.
- Experience: 2 to 7 years in a regulatory approved plant (Formulation or API).
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🏢 Expert Pharmaceuticals
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