CSV/Validation Specialist

Princeton, New Jersey
Industry: QA Testers
Job Number: JN -072021-67622

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
  • Release to Production Statements
  • Direct and review testing
  • Provide guidance on quality issues that affect the integrity of the data or the system
  • Obtain and respond to QA review
  • Participate in establishing standard quality and validation practices
  • Independently assess compliance practices and recommend corrective actions
  • Approve validated computer system related change requests
  • Monitor regulatory and inspection trends and advise the business on suitable action
  • Ability to create documents to an existing document standard.
  • Able to develop all documentation required for a 21 CFR Part 11 validated project, including Validation Plans and Summaries.
  • Advanced knowledge of complete MS Office suite and Visio. Firm understanding of technology platforms as needed for project.
  • Experience with electronic document management systems (e.g., documentum, Qumas, SharePoint etc.); application development and lifecycle management (e.g., HP ALM, JIRA, etc.); and IT service management systems (e.g., ServiceNow, SAP Solution Manager, etc)
  • Excellent oral and written communication skills in English. Strong expertise and ability to interview and accurately interpret communication requirements of team members.
  • Once trained, have the ability to work independently on CSV projects with minimal oversight.

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