Experience

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  Hcltech

  Jan 2007 - Jan 2009

  Process executive
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  Cognizant

  Feb 2009 - Jul 2010

  Senior process executive
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  Wipro

  Jan 2010 - Jan 2013

  Consultant

  Worked as Q&C for Computer system validation.

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  Deloitte

  Jan 2013 - Sept 2016

  Consultant

  Working for one of the biggest US pharma client Johnson&Johnson..“Data Conversion Activities” for SAP MDM (Module), Perform Quality and Compliance reviews for various SAP modules.• Review Test scripts from HPQC and approve them.• Reviewing the FDS, work instructions document, from quality perspective and approving them.• Raising defects and notifying it to the team during discrepancies.• Initiating bridge calls with clients for KT sessions and discuss about the various SLA's and deliverables and providing status report of the project.• Prepared status Report of Deliverables on weekly basis and send it to the client.• Responsible for Document management through SharePoint. Weniger anzeigen

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  Infosys consulting

  Jan 2016 - Jul 2020

  Consultant
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  Regenold gmbh

  Aug 2020 - Feb 2021

  Senior validation specialist

  • Process enhancements on QMS by creating, updating, reviewing SOPs, Work Instructions, templates.• Manage the Demand and cost estimate of the resources and act as Validation expert and provide pragmatic solutions to the customers.• Developing Quality Frame Work and play active role in Stake Holder Management.• Responsible for End to End system Validation Activities performed.• Understand the system and prepare the High level documents like Project Documentation List, CAPA management, Validation Plan, Test summary report, Traceability matrix, Test overview list, Deviation Log, Data Migration Plan, Validation report, Functional Risk Assessment, Project Control Maturity Assessment, Privacy Impact Assessment, Third Party Assessment documents.• Schedule calls with various stake holders of the project to discuss on the control Maturity assessment of the project. Weniger anzeigen

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  Arcondis group

  Jan 2021 - now

  Management consultant

  • Responsible for End-to-End system Validation Activities performed and prepare the High-level documents like Project Documentation List, CAPA management, Validation Plan, Test summary report, Traceability matrix, Test overview list, Deviation Log, Data Migration Plan, Validation report, Risk Assessment, Privacy Impact Assessment, Third Party Assessment documents.• Response as CSV service Owner in the Organization.• Managing the Team of 26 CSV professionals.• Conduct Workshops on compliance topics based on client needs.• Identify the problem statements from Customer and provide pragmatic solutions.• Manage demands and provide effort estimation.• Work on RFP to translate them to opportunities.• Business development.• Manage large CSV programs with multiple FTE’s.• Perform GAP Analysis and remediate them.• Developing the CSV approach and Validation Framework.• Training new hires/consultants on nuances of Computer software assurance and implementation of lean approach.• Collaborate with various Stake Holders in discussion pertaining to High level Risk assessment.• Schedule calls with various stake holders of the project to discuss the status and project governance.• Managing the Change request and performing Impact assessment.• Ensure the system is attained in Validated state by updating various operational SOP’s. Weniger anzeigen