Principal task: 1) Monitoring Analytical method development, Validation study and method transfer activities. 2) Review the analytical method development data, validation study data and method transfer protocol and reports. 3) Preparations of justifications 4) To maintain and observed GLP/GDP in working environment. 5) Investigation Study as per requirement. Responsibilities: 1) Review of analytical method validation and method transfer protocol and report as per the current regulatory requirement. 2) Review Regulatory Queries of product receiving form different regulatory agencies. 3) Preparation and review of standard operating procedure. 4) Maintaining HPLC calibration report. 5) Trouble shooting during day-to-day analysis with proper instrument care. 6) Taking care of Analytical HPLC Spare. 7) Maintain records for all analytical reports by entering all the data and timely release the analytical reports to concern dept. 8) Maintain Coordination with Plant site during Method transfer activity.
