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
