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CSV - Trackwise (OnPrem) Validation Lead

Job Order #015796
  • Posted On: June 22, 2020
  • Position Title: CSV - Trackwise (OnPrem) Validation Lead
  • Position Type: Contract
  • State: California
Job Summary:
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Phil West is recruiting this position.


Our client located in California is seeking a Trackwise Validation Lead for a 6 month + contract role.


  • Our client is looking for Validation Lead to lead the client’s validation efforts and coordinate validation activities. Successful candidates will have previous experience using TrackWise, previous experience leading validation teams and will utilize their knowledge of FDA cGMP and related regulations and guidelines, specific knowledge of computer validation methodologies and principles to perform CSV on a variety of systems and programs. 
  • 5+ years of Trackwise Validation Lead project experience is required. OnPrem Version is required
  • 5+ years’ experience validating GxP systems in a FDA regulated environment
  • 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
  • Assist in developing and documenting and reviewing User, Functional and Design requirements; traceability matrix documentation; Infrastructure Qualification and change control
  • 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.
  • Participate in the identification of risks and the development
  • Excellent communication skills are required
  • Start date is ASAP
  • Remote work 

To learn more about this and other positions, contact Phil West at 978-561-2016 or pwest@healthcareitleaders.com. Healthcare IT Leaders is a national leader in IT workforce solutions, connecting healthcare provider, payer and life sciences organizations with experienced technology talent for consulting and full-time hiring. For more information, visit us on the web at www.healthcareitleaders.com.

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