Experience

• 

  Pfizer

  Sept 2007 - May 2008

  Medical representative
• 

  Sanofi

  Jun 2008 - May 2009

  Trainee, qa

  In process check, Batch record review, APQR preparation

• 

  Claris limited

  Sept 2009 - Nov 2010

  Officer, cqa

  APQR review, Vendor Audit & Self inspection.Batch record review.

• 

  Zydus group

  Nov 2010 - Feb 2017

  IPQA, Batch Release, QMS, Documentation management, Self inspection, Regulatory audit handling & response. IPQA, QMS, Self Inspection, Process Validation, Regulatory query response. IPQA, QMS, APQR, Validation, Batch records review and release for commercial & Exhibits. Responsible for Green field project at site, Qualification, Validation, IPQA, APQR, Documentation.

  • Deputy Manager Quality Assurance

    Apr 2016 - Feb 2017

  • Executive, QA

    Apr 2014 - Mar 2016

  • Officer, QA

    Apr 2012 - Mar 2014

  • Sr Technical Supervisor, QA

    Nov 2010 - Mar 2012
• 

  Baxter international inc.

  Feb 2017 - now

  QMS handling for Non conformance, CAPA, Change Control, Self Inspection, Product Development Life Cycle Management, PQDR, Audit handling and response, Risk Management, Training Management, Document Management, Quality KPI monitoring, Management Review Meeting Quality System Integration completion, Implementation of Global document at site, Trackwise8 Implementation at site. Conduct training for trackwise8 access. QMS handling for Non conformance, CAPA, Change Control, OOS, Audit handling and response.Self Inspection, Management Review meeting. Quality System Integration, Implementation of Global document at site, Trackwise Implementation for QMS elements at site.

  • Supervisor- Product Quality at Baxter

    Oct 2022 - now

  • Senior Associate Quality-QMS at Baxter Pharmaceuticals India Pvt. Ltd.

    Apr 2019 - Sept 2022

  • Assistant Manager-CQA at Baxter Pharmaceuticals India Pvt. Ltd.

    Feb 2017 - Mar 2019