SWAPNIL BORADE

Experience

• 

  JOTIBA TECHNOLOGIES PVT LTD

  Mar 2015 - May 2017

  Design and Development Engineer
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  Wockhardt Ltd.

  May 2016 - May 2017

  Apprentice

  Responsible for engineering QMS, Calibration and HVAC

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  Harman Finochem Ltd

  Oct 2017 - Nov 2018

  Officer

  Responsible for engineering QMS, Computer system validation, Calibration, Qualification

• 

  Ajanta Pharma Ltd

  Nov 2018 - Aug 2022

  Officer

  Computer System Validation, Engineering documentation QMS, Training, Risk Assessment

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  Capgemini

  Jul 2022 - now

  Consultant CSV

  1. Responsible for overall CSV (Computer system validation activity.2. Responsible for authoring and review the SDLC Validation documents like Validation plan, Validation summary report, GxP Risk assessment, Functional risk assessment, Installation qualification, operational qualification, Performance qualification (UAT), Requirement traceability matrix, Test plan & Test summary report, System/user requirement specification, functional specification, Configuration/ design Specifications documents, Infrastructure requirement specification, System description, supplier assessment, critical data assessment, trainings / user manuals, CMDB etc.3. Handling change management Activities.4. Handling SAP (S4HANA & ECC) validation projects.5. Responsible for review & approve test scripts/ Test runs (Functional, Integration, IQ, UAT, regression, performance) & defect management.6. Ensuring the process is followed as defined and in compliance. Ensure Compliance of 21 CFR part 11 and GAMP-5 guidelines.7. Interacting with all the stakeholders to understand the business requirements.8. Team management.9. Tools handling:Testing tools- JIRA-Xray, HP ALM, Code beamer Document management- Veeva, GDRS, EDMS, Microsoft office Change management- SNOW, CHARM, Trackwise Show less