What are the responsibilities and job description for the Computer system validation Engineer (CSV) position at Katalyst CRO?
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.