Job Responsibilities: Understand and analyze requirements, define tasks and execute them. Involve in preparing documentation for all aspects of the computer system validation life cycle. Design, deliver, support and maintain GxP computerized systems and security of the associated data. Create and review validation plans, user requirement specifications, functional/design specifications, system integration and user acceptance test design and traceability matrix. Validate models for risk management and compliance. Coordinate with offshore team in an onsite-offshore model. Skills Required: CAPA CGXP GAMP
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