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Life SciencesCSV Clinical Trial Systems Validation

 

Duties / Expectations of Role
  • Generate validation deliverables which includes Val Plan, Risk Assessment, URS/RS/CS requirements docs, IQ/OQ/PQ protocols
  • Develop and maintain test plans, test scripts and user acceptance tests and manage the execution of test plans
  • Evaluate proposed changes to validated computer systems and recommend level of validation activities required
  • Ensure initiation/preparation and closeout of all CSV related deviations, discrepancies and change control documents
Mandatory Requirements
  • 6+ years of experience with CSV AND minimum 3+ years within Clinical (Clinical Trial Management Systems, IxRS)
  • Experience with 21 CFR Part 11, GCP, ICH Q9, GAMP5, Data Integrity principles
  • Experience with test scripts execution and review
  • Experience with Deviations, CAPAs and Change Request creation
  • Experience with paperless execution (HPALM preferred)
Term & Start

· Long term contract

· Initial contract through the end of 2020 with annual renewal

· Onsite in Marin County, CA (after shelter in place is lifted)

· Start in June 2020

Please send CVs to vijaya@fusionlifesolutions.com

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