Principal task: Analytical Method Development by HPLC for all Project. Review the analytical method development data, validation study data and method transfer protocol and reports. Calibration of HPLC system. To maintain GLP/GDP in working environment. Preparation of analytical data and submit for review. Analytical Method Development and Validation. Responsibilities: Calibration of HPLC’s as per SOP and maintenance of HPLC Systems. Maintaining record for all analytical reports by entering all the data in raw data note book and timely release of analytical reports. Preparation & Review of analytical method validation protocol and report as per the current regulatory requirement. As per Protocol, perform the Analytical method validation of RS, Assay and Chiral for KSM, Intermediate and Finish product of compendia and non-compendia compound. Preparation & Review of Protocol & report of analytical method transfer report. Maintain records for all analytical reports by entering all the data and timely release the analytical reports to concern department.
