Suresh Arora

About Suresh Arora

IT professional with 7+ years of Experience in Computer System Validation/ IT-Regulatory Compliance.Roles/responsibilities and skill-set:End to End Validation planning and Project execution for IT systems in GXP (GCP, GMP, GLP) Area. Review and Approve GXP document.Also worked as a Bio statistical Programmer in SAS.Conduct Software system validation activities for core software applications and customized solutionswithin agreed timelines. GXP and Risk AssessmentWorking with both CQA and IT departments on validation front.Conduct comprehensive IT systems validation in close cooperation with all involved departments within IT projects: work closely with project team members and IT vendors throughout the entire ITsystem/software development life cycle.Guide project team to deliver as per FDA guidance. Worked with CQA team for updating the change management SOP.Responsible for defining/documenting validation strategy for GXP IT systems.CSV Documents (Validation Plans, Validation Reports, Release Plans, and Release Reports, Requirements, Designs, Test Plans, Test Scripts,Requirements Traceability Matrix, Test Results, andTest Summary Reports). Performed Periodic review of GXP System.Change Management and Incident ManagementInvolved in documentation of Lifecycle development for CSV (IQ, OQ, PQ) and SDLC processes. 21 CFR PART 11,

Experience

1. Sr Design Quality Engineer

   美敦力

   Jan 2025 — Present

   Working as a senior DQE for Medtronic supporting med devices for Neuroscience- ENT domain.

Education

• BBDNIIT

  Bachelor of Technology - BTech, Information Technology

  2012 — 2016