Responsible to take training before execution of allotted work.
Responsible to follow safety precaution as per laboratory procedure.
Responsible to escalate any issue / incident to reporting manager for prompt corrective action.
Responsible for execution of characterisation activity for drug substance and drug product using analytical technique such as LCMS, GCMS, HRMS, GC and HPLC.
Responsible for identification of extraneous peaks by LCMS, HRMS and GCMS.
Responsible for method development and pre-validation of Nitrosamine impurities & Genotoxic impurities by LCMS and GCMS.
Responsible for method development and support to carryover studies and FDA queries by LCMS, GCMS and HRMS for Nitrosamine impurities & Genotoxic impurities.
Responsible for review of raw data related to instrument calibration and analytical raw data generated in laboratory.
Responsible for review and approval of change control, incident/event investigation reports.
Responsible to support plant in investigation of event/OOS/OOT etc.
Responsible for method validation and method transfer.
Regulatory guideline knowledge for US & other advanced markets.
