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Title:  Executive - Analytical Development

Date:  Nov 13, 2024
Location:  Tandalja - R&D
Company:  Sun Pharmaceutical Industries Ltd
  • To work as per cGMP and ensure its compliance.
  • 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.

 

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