Kiran Kumar A

Kiran Kumar A

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location of Kiran Kumar ABengaluru, Karnataka, India

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  • Timeline

  • About me

    Head Computer System validations & Compliance at Arcolab Private limited

  • Education

    • MVJ College of Engineering, Bangalore, India

      1999 - 2004
      Bachelor of Engineering - BE Chemical Engineering
  • Experience

    • Cipla

      Jun 2004 - Jun 2005
      Officer

      Planning, Process Monitoring ,Man Management, CAPA, Deviation Handling, Validation

    • Bostik India

      Jun 2005 - Aug 2008
      Executive

      Production Planning and execution,Process Monitoring, Man Management

    • Flint Group

      Aug 2008 - Dec 2010
      Executive

      Equipment Validation , Planning, Material Management, Man Management

    • IVYWorks

      Jan 2010 - Aug 2014
      Validation Manager

      Computer System Validation

    • Novo Nordisk

      Aug 2014 - Apr 2015
      Business Analyst

      Computer System Validation

    • Strides Shasun Limited

      Apr 2015 - May 2017

      Develop and Review Project Validation Plan, Impact assessment Document, Functional Risk Assessment, Qualification Documents, Period review documents.Change Controls, Deviation Management, CAPA.Manage team Validation of Computer systems as per the Validation SDLC, 21 CFR PART 11, Annex 11

      • Computer System Validation

        Apr 2015 - May 2017
      • Validation Specialist

        Apr 2015 - May 2017
    • Eurofins IT Solutions India Pvt. Ltd

      May 2017 - Feb 2021
      Process Manager

      Implementation of GxP Process across the Labs in multiple Geographies, Computer system validation and compliance. Risk management and regulatory compliance. Audit management.

    • Apotex Inc.

      Feb 2021 - Mar 2024
      Deputy General Manager CSVC and Scientific apps

      Manage the team of Computer System validation, IS Scientific application teams, ensure Data integrity in all computer systems. Operation and management of Scientific Systems. 21 CFR Part 11 , 21 CFR Part 211.68.

    • Arcolab

      Mar 2024 - now
      • Head

        Dec 2024 - now
      • Associate Director

        Mar 2024 - now
  • Licenses & Certifications