JDA details of Q.C Manager Exp: 12 to 15 yrs Company : pharmaceutical preferably in a regulatory Plant. Job profile : 1 . Knowledge of GLP documentation and good equipment is must. Instruments Knowledge § High Performance Liquid Chromatography. (Shimadzu LC-20 AT) § UV/Visible Spectrophotometer.(Shimadzu 1700-1800) § FTIR Spectrophotometer. (Shimadzu FTIR-84005) § Dissolution Test Apparatus. (Electro lab TDT-08L) § Disintegration Test Apparatus. (Electro lab EAD-2AL) § KF Titrator (Spectra lab MA-101C) § Preparation of Volumetric solution. § Tapped density apparatus etc. Ø Documentation section : Documentation section of quality control deals in: § The preparation and regular review of SOPs, STPs, data sheets and formats. § Packing materials related documentation & Testing. § Maintain controlled documents distribution register of inter depart. § Procure reference standards and monitor working standard qualifications. § Stability study as per (ICH guidelines). § Handling of preventive maintenance program for all instruments. § Review laboratory investigations related to OOS, OOT, Incidents, and Deviation etc. Ø Budget preparation and inventory management – Quality Control § Annual budget preparation of the department. § Evaluate required resources like chemicals, columns, spares, etc.
Posted on: Thu, 15 Jan 2015 07:09:30 +0000