Computer system validation Engineer (CSV) Job at cGxPServe, Bridgewater, NJ

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  • cGxPServe
  • Bridgewater, NJ

Job Description

Roles & Responsibilities:
  • Experience designing, implementing, and operating IT risk management, IT quality and IT compliance activities in a life sciences organization, with particular focus on GxP, IT internal controls, SDLC management.
  • Experience designing, implementing, and navigating waterfall and agile SDLC (System Development Life Cycle).
  • Experience in SAP/ERP Validation and test management.
  • Experience leading IT risk, IT quality and IT compliance transformational programs.
  • Experience in executing Change Control, and Document management.
  • Experience with IT Quality Management Systems and CAPA management systems.
  • Experience designing IT risk, IT quality and IT compliance operating models.
  • Experience designing and implementing IT quality and compliance life sciences controls for cloud products.
  • General IT strategy experience.
  • Knowledge of IT systems, applications and tools required .

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