Chemist Job

Chemist is needed to perform the following duties:

• 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.

Bachelors degree is required in Chemistry or Pharmaceutical Science