Description
Position Description :
Position ensures that the products provided to the market are tested as per customer specifications and in compliance with applicable pharmacopoeias as well cGMP/GLP/ICH/USFDA/ISO guidelines.
Key Responsibilities:
Analysis of Finished products / raw materials/ in process & stability samples (Wet & Instrumental analysis). Preparing stability trend and then sharing with all stake holders. Conducting LSC to update all stake holders on stability status. Calibration of HPLCs as per defined procedure and schedule. Method validations as per applicable guidelines. Inventory management of reagents/columns spares etc. required for Premix analysis. Mobile phase preparation and their record keeping. Printing and preparation of record of analysis. Log books management for various activities. Preparation/Revision of method of analysis. Revision/Preparation of specifications in consultation with Purchase and other departments. Reporting of deviations in analysis as per LIR procedure and implementation of CAPA. Day to day handling of hurdles for smooth analytical work (Trouble shooting of instruments). To ensure good housekeeping in the working area as well as in surroundings. Conducting of stability studies of Premix for validation batches/Annual batches. To ensure compliance to all SHE guidelines and to ensure safe working.
Requirements
Post-Graduation in Chemistry. Knowledge of cGMP & GLP guidelines, ICH/ USFDA guidelines. Working knowledge of Method development and validation. Handling of instruments like HPLC/GC/GCHS/Spectrophotometer etc. Minimum 6 years of experience in Pharmaceutical industry and extensive Quality control experience in API manufacturing industry.
