Senior Executive

Department Details Role Summary Primary responsibilities 1 Ensure Implementation of Data Integrity Culture in Quality Control Lab 2 Adherence to cGMP Current Good Manufacturing Practice cGLP Current Good Laboratory Practice and GDP Good Documentation Practice 3 Performing stability related activity 4 Receipt of in process DS reserve samples and stability samples and storage at QC location 5 Preparation qualification and life cycle management of cell banks used in bioassays 6 Planning and review In-Process finished product and stability sample testing of monoclonal antibodies and biosimilars and reporting the results 7 Review of analytical reports of In process finished product stability method validation method transfer and study Review of usage log books and Observation data sheets 8 Preparation and review of method validation method transfer study protocol Stability protocols and summary sheet Compilation Data and reports 9 Planning and performing Testing of method transfer method validation and study samples 10 Verification of laboratory compliances which include the validity checking of the reagents standards system status etc 11 Reporting and investigation of Incidents OOS OOT and Deviation 12 Supporting Operational Excellence 5S in Quality control Lab 13 Calibration of analytical weighing balance pH meter etc 14 Various monitoring such as lab and equipment and cleaning of labs activities Secondary responsibilities Wherever applicable 1 Cross functional coordination with all the inter departments for smooth flow of activities 2 Supporting to other QC functions QMS inter sectional activities when required 3 Any activity assigned by supervisor manager apart from the primary responsibilities Key Responsibilities Primary responsibilities 1 Ensure Implementation of Data Integrity Culture in Quality Control Lab 2 Adherence to cGMP Current Good Manufacturing Practice cGLP Current Good Laboratory Practice and GDP Good Documentation Practice 3 Performing stability related activity 4 Receipt of in process DS reserve samples and stability samples and storage at QC location 5 Preparation qualification and life cycle management of cell banks used in bioassays 6 Planning and review In-Process finished product and stability sample testing of monoclonal antibodies and biosimilars and reporting the results 7 Review of analytical reports of In process finished product stability method validation method transfer and study Review of usage log books and Observation data sheets 8 Preparation and review of method validation method transfer study protocol Stability protocols and summary sheet Compilation Data and reports 9 Planning and performing Testing of method transfer method validation and study samples 10 Verification of laboratory compliances which include the validity checking of the reagents standards system status etc 11 Reporting and investigation of Incidents OOS OOT and Deviation 12 Supporting Operational Excellence 5S in Quality control Lab 13 Calibration of analytical weighing balance pH meter etc 14 Various monitoring such as lab and equipment and cleaning of labs activities Secondary responsibilities Wherever applicable 1 Cross functional coordination with all the inter departments for smooth flow of activities 2 Supporting to other QC functions QMS inter sectional activities when required 3 Any activity assigned by supervisor manager apart from the primary responsibilities Educational Qualifications Required Education Qualification Msc Required Experience 3 - 8 years