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.
Work Location: In person
