Senior Manager

Principal task and Responsibilities : Senior Analyst Major purpose of the Job : 1) Analytical Method Development and Validation, Method Transfer by LC-MS for all API Project. Prepares MOA Protocol and that basis execute the validation and finally prepared the report. 2) Tuning the system, API and select the MRM. 3) Plant Release Sample and Plant cleaning sample analysis by LC-MSMS, fill up TDS, and submitted COA at Ankleshwar QC. 4) Routine LC-Mass Analysis for Intermediate, in process and final API as per the specification and Standard test procedure 5) Calibration of LC-Mass system and prepared report 6) To maintain GLP in working environment. 7) Regularly requirement co-ordination with project scientist. 8) Preparation of analytical data and submit to concern project scientist. 9) Co-ordination with service engineer and do the trouble shooting as per instruction. Responsibilities: 1) Developed and validate New LC-Mass Method for all stages of new API Molecule as well as modified old method as per regulatory requirement. 2) Plant Release Sample and plant cleaning sample analysis by LC-MSMS, fill up TDS, and submitted COA at Ankleshwar QC. 3) Routine LC-Mass Analysis for Raw Intermediate, in process and Final API as per specification ans Standard test procedure. 4) Calibration of LC-Mass as per SOP and maintenance of LC-Mass system. 5) Trouble shooting during day to day analysis and discuss with R&D people of respective project. 6) Maintaining record for al analytical reports by entering all the data in raw data in raw data note book and timely release of analytical reports. 7) Preparation of MOA, Protocol and report of LC-Mass analytical method.\ 8) Provide training to the juniors. 9) To maintain analytical data and reports.

lc-ms, method development, method validation, lc-msms, glp compliance, calibration, analytical method transfer, analytical data management, standard operating procedures, troubleshooting, plant release sample analysis, plant cleaning sample analysis, analytical reporting, project coordination, training delivery