Ellappan K A

Experience

• 

  MEDOPHARM

  Sept 2001 - Apr 2007

  QC Executive

  QC analyst

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  Dr. Reddy's Laboratories

  May 2007 - Oct 2009

  Junior manager

  QC documents reviewer cum Group leader

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  Micro Labs Ltd

  Oct 2009 - May 2013

  Manager QC

  Section head for RM & GLP team

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  Cipla Ltd

  May 2013 - Dec 2015

  Head of Laboratory Quality Assurance

  • Overall responsible for the compliance with respective cGLP/cGMP in the Quality Control Laboratory• Responsible for internal/external & regulatory audits coordination • Derived the investigations on analytical incidences, OOS/ OOT, OOAC/OOAL of chemical and microbiological test results• Derived and monitored the CAPA, deviations & change requests (QMS) which are related to Quality • Ensured various activities of administrator for various software’s in the laboratory (i.e. user Id creation/modification, review of audit trails, users privileges assignment, report templates creation/modification, monthly folder creation and back-up)• Execution and review of instruments/equipment’s qualification & Computer System Validations (CSV)as per GAMP 5• Ensured training has been imparted to the analysts/QA officers in view of laboratory techniques, CQA’s & Quality control procedures etc.• Review of SOP’s which are belongs to Quality functions. Show less

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  Strides Pharma Science Ltd

  Dec 2015 - Jun 2022

  Sr. Group Leader - QA

  • To conduct audits (SME in QC) across the strides shasun units and review of compliances & effectiveness of CAPA’s• Conducting the training to QC & QA personnel’s regarding audits observations and recommendations.

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  STERIL-GENE LIFE SCIENCES

  Jun 2022 - now

  • Deputy General Manager - QC

    Jun 2022 - now

  • Head of Quality Control

    Jun 2022 - now