Ganesh Khedkar

Experience

• 

  Sitec Labs Pvt Ltd

  Aug 2021 - Jun 2022

  Research Associate Trainee - Bioanalytical

  Performing Method Development and Method Validation using analyticalInstruments HPLC ,LC-MS/MS and ICP-MS.Review of raw data of respective method book, method validation, partialmethod validation, study as and when required.Prompt and accurate analysis of drug, plasma and biological samples in strictaccordance with GLP and GCP approved SOP and protocol.To control and issue the documents i.e. SOPs, forms, formats, log books,study specific protocols, validation protocols, qualification protocols of alldepartments of BEC site as per SOP.Bioanalytical Subject Sample Analysis using SPE Method, ProteinPrecipitation Method, Solid Phase Extraction, Liquid Liquid ExtractionMethods.Review equipment installation, qualification, calibration and preventivemaintenance in Bioanalytical and verify that these activities are conducted asscheduled. Show less

• 

  Glenmark Pharmaceuticals

  Jun 2022 - Oct 2023

  Research Associate - Clinical Research and Pharmacokinetics

  Review of BA/BE Protocols.Performing Method Development and Method Validation using analyticalInstruments HPLC ,LC-MS/MS and ICP-MS.Responsible for planning and executing the QA activities for Bioanalytical,Pharmacokinetics and Biostatistics departments.Ensure compliance to SOP, GCP/GLP and applicable regulatory guidance’sReview of raw data of respective method book, method validation, partialmethod validation, study as and when required.Monitor the bioanalytical projects to ensure that all the data of thebioanalytical phase is audited before submission of study report tosponsor.Review equipment installation, qualification, calibration and preventivemaintenance in Bioanalytical and verify that these activities are conductedas scheduled.Audit each BA/BE studies (both pre and post study) to assure themanagement that the facilities, personnel, equipment, instruments,protocols, methods, practice, records and controls are in conformance withthe relevant and current GCP / applicable GLP guidelines, protocols andSOPs implemented as per SOP.Review the SOPs, forms, formats and log books of all the department(s)and give comments on the same.To control and issue the documents i.e. SOPs, forms, formats, log books,study specific protocols, validation protocols, qualification protocols of alldepartments of BEC site as per SOP.Review of PK data, statistical output of clinical study as per therequirement. Show less