Essential Duties and Responsibilities: |
• Sampling and testing of raw materials per approved procedure. |
• Physical and chemical testing of bulk and (pre-fill, finished product, and stability) product. |
• Upkeep of laboratory notebook. |
• Maintaining the work area in an orderly manner. |
• Maintaining Lab inventory like list of standards, chemical, reagent etc. |
• Recording daily activity like PH verification, balance verification, temperature and humidity monitoring of lab stability chambers, freezer, refrigerator etc. |
• Experience in the operation of handling QC major instruments like HPLC, GC, UV, IR, Auto titrator, etc. |
• Perform Finished product/in-process/cleaning validation and raw material analysis independently. Complete testing within specified timeframes and document results accurately |
• Coordinate with vendor for instrument PM, calibration and qualification activity. Provide necessary support. |
• Maintain and monitor lab GLP activity like instrument calibration/qualification schedule, Preparation of instrument operating procedure, coordinate with metrology team and vendor for scheduling period calibration/qualification activity etc. |
• Performs calibration of lab instruments whenever possible. |
• Cleaning of laboratory glassware. |
• Responsible for writing SOP for instrument operation/ calibration etc. |
• Provide necessary support for OOS/OOT investigation. |
• Preparation of stability schedule, Protocol, and report per ICH requirements. |
• Adhere to regulatory guidelines (e.g., FDA, ICH, GMP) and company quality standards during testing and documentation. |
• Ensure adherence to Good Laboratory Practices (GLP), Good Documentation Practices (GDP), and Good Manufacturing Practices (GMP) during testing procedure. |