Validation Lead with Track wise
San Francisco , CA
6 months
· Need Validation Lead with Track wise experience.
· Testing/validation of GxP Systems
· Assist in developing and documenting and reviewing User, Functional and Design requirements; traceability matrix documentation; Infrastructure Qualification and change control
· Author Validation Plans, System Risk Assessments, Installation, Operational and Performance Qualification protocols (OQ/PQ)
· Execute test protocols (OQ/PQ), perform/support system development, testing and validation activities per current Standard Operating Procedures and guidelines.
· Coordinate validation activities including test execution and status reporting, deviation documentation and resolution.
· Author Test and/or Validation Summary Reports;
· Collaborate with Technical team, Business stakeholders, QA specialists in Quality/Compliance and ensure GxP systems are validated and in compliance.
· Participates in the identification of risks and the development of mitigation strategies for project.
· Coordinate, manage and monitor deviations/defect reports and work with developers and other project team members to resolve).
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