Amit Mangale

Experience

• 

  Emcure Pharmaceuticals Limited

  Sept 2007 - Nov 2010

  Engineer - Instrumentation.
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  Sai Life Sciences Ltd

  Dec 2010 - Jan 2015

  Sr. Executive-Projects & Engineering.
• 

  Cipla

  Feb 2015 - Jan 2016

  Management Staff (BMS, CSV & QMS)

  Responsible for Quality Management System, Computer System Validation, Equipment and Instrument qualification and validation. Building Management system implementation and compliance of regulatory guidance.

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  Wockhardt Ltd.

  Jan 2016 - Jun 2017

  SENIOR EXECUTIVE (CSV, QMS and Engineering Compliance)

  Responsible for Quality Management System, 21 CFR part 11 Equipment Complaince,Track wise Online system _ Change Control, CAPA, Deviation, Learning Management System, Engineering Projects, Calibration,Validation.

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  Ajanta Pharma Ltd

  Jul 2017 - Mar 2023

  Deputy Manager CSV and QMS

  A computer system validation specialist coordinates validation efforts for computer systems, hardware, and software, especially within a manufacturing setting, to ensure product quality.Responsible for Quality Management System, Computer System Validation and Assurance and Validation and Qualification of Equipment s and Software's.Internal and External Auditor, ISO Qualified internal auditor.SOPs implementation, GAMP5, CSV, USFDA, Annex 11, 21 CFR Part 11.

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  Glenmark Pharmaceuticals

  Mar 2023 - Feb 2025

  Manager CSV and GxP Compliance (Digitalization)

  Responsible for CSV and GxP Compliance for Pharmaceuticals, Healthcare and Medical Devices Application & Software's.Expertise in Guidelines of GAMP5 (CSV, CSA & 2nd Edition of GAMP), 21 CFR Part 11, Annex 11, EudraLex, ISO.Validation and Qualification of Equipment, Instruments and Software in pharmaceuticals industries. Write, review, and approval of validation SOPs and documentation.Implementation of Quality Management Systems and Project Validation Plans including High Level Risk Assessment approaches.Time Management, Team Management, Quality Assurance, Engineering, Digitalization and Projects. Show less

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  Alkem Laboratories Ltd.

  Jan 2025 - now

  Corporate Lead CSV, IT GxP Compliance and GCC_Global Functions.

  Leading CSV functions Globally, IT GxP Compliance and GCC (Global Capabilities Center).