Validation Specialist
The Judge Group Inc.

Princeton, New Jersey


Location: Princeton, NJ
Description: Our client is currently seeking a Validation Specialist to provide guidance on quality issues that affect the integrity of the data or the system.

This job will have the following responsibilities:

  • Apply FDA, MHRA, and other applicable global health authority regulations to the development of computer systems supporting regulated business processes
  • Follow SOPs and industry best practices Possess Expertise on Good Documentation and Good Testing Practices, in order to train those within the business that are less familiar.
  • Facilitate the Computer system Validation Risk Assessment to identify governing regulations and validation deliverables during the development of the computer system Review validation deliverables for projects which are contracted to third party suppliers
  • Maintain close communication with stakeholders and team members to keep apprised of computerized system needs, impacts on computer validation, project validation status, and other relevant issues Assist in planning, implementing, and documenting user acceptance testing
  • Review computerized systems validation documents such as: Requirements Specification, Design Specification, CSV Risk Assessment, Test Plans, Test Summary Reports, Data Migration Plan, Pre/Post Executed Test Scripts, Traceability Matrix and Release to Production Statements
Qualifications & Requirements:
  • 5+ years of experience in managing the projects as CSV specialist /lead
  • 5+ years of experience in testing, script reviewing from a QA perspective in particular
  • 5+ years of experience in authoring , reviewing various validation documentation
  • Good communication and writing skills
  • Data Integrity experience is a plus
Contact: wsill@judge.com

This job and many more are available through The Judge Group. Find us on the web at www.judge.com


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