Abhijeet Roul

About Abhijeet Roul

Healthcare professional with 17 years experience focusing on Quality for Pharmaceutical…

Experience

1. Assistant Manager

   Torrent Pharmaceuticals Ltd

   Jul 2023 — Present

   Leading QA of 42 team members in Shop floor (Manufacturing, packingand Warehouse).Managing Quality Management system (Change control, Deviations,Market Complaints & CAPA’s).Managing all Quality Functions in Shop floor (Manufacturing, packingand Warehouse).Involved in Internal Audits as well as external audits and auditcompliance.Involved in audit compliance, verification and validation of auditCAPA\'s.Coordination and planning with cross functional teams for Day-to-Dayactivity.Review, implementation and validation of Corrective and Preventiveaction.Preparation, Review and compliance of Process Validation protocolsand there reports.Review and compliance of batch documents and final batch release ofproducts to market.Preparation, review and approval of SOP\'s. through Trackwise.Audit trial review and alarms of the equipment\'s.Involved in Qualification of new Area & Equipment’s.Involved in Continuous Process Verification Programme andpreparation of CPV monitoring plan.Review of Investigations such as Deviation, OOS and OOT.Review of batch documents through MES (Manufacturing executionsystem).Master BMR & BPR Approval through LMS.Review and Approval of Change Controls through Trackwise system.Involved in regulatory Audits and there compliance such asUSFDA,MHRA and other customer Audits.

Education

• Loyola Institute Of Business Administration

  Executive Post Graduate Program in Healthcare Management, Health/Health Care Administration/Management

• Biju Patnaik University of Technology, Odisha

  Bachelor's degree, Pharmacy

• Institute of Good Manufacturing Practices India (IGMPI)

  Postgraduate diploma , COMPUTER SYSTEM VALIDATION