Padmanabhan G M

Experience

• 

  ClientLogic

  May 2005 - May 2007

  Technical Support Executive

  Supporting overseas clients with technical issues for internet issues

• 

  Omega Healthcare Management Services Private Limited

  Sept 2007 - Jan 2009

  Medical Coder

  Coding of the medical conditions in the medical reports as per the ICD and CPT guidelines, QC, training of new joinees...

• 

  Biocon

  Jan 2009 - Apr 2013

  Senior Executive

  Quality AssuranceEnd to end compliance support to validation of computerized systemsQualification, requalification and calibration of equipment and instruments in the laboratoryData analysis; data review and auditing of laboratory results and production documentationReview of documents pertaining to DMF in accordance to regulatory normsTo write, review and revise Standard Operating ProceduresEnsuring compliance with regulations and guidelines

• 

  ArisGlobal

  Apr 2013 - Nov 2017

  Validation of GxP software applications on hosted Cloud platform (SaaS model)End to end compliance support to validation of software for pharma domain.Good Knowledge on GAMP, 21 CFR Part 11, ICH guidelines, GxP regulations, FDA and EUGMP regulations, Computer system validation, global regulatory requirements for pharmaceutical industry,Manage audits (Internal and External).

  • Manager

    Apr 2017 - Nov 2017

  • Associate Manager

    Apr 2016 - Mar 2017

  • Team Lead, Compliance

    Apr 2013 - Mar 2016
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  Prudentia Group, LLC

  Nov 2017 - now

  Manager- QA & Validation