100% Remote Lead Validation Analyst (ABV)

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  • Location: North Chicago, IL
  • Type: Contract
  • Job #15779

The recruitment team at Myticas Consulting is looking for an experienced Lead Validation Analyst who would be interested in a remote contract opportunity offered within the Norther Chicago, IL region.

Top 3-5 Requirements:

  • 21 CFR Part 11, authorising risk assessment, e-record & signature assessment
  • Risk assessment processes
  • Work cross functionally, working with system owners/tech team
  • Strong comm skills, comfortable leading the discussion.

Nice to have:

  • Documentation
  • MS Suite
  • ServiceNow is a Plus

Job Description:

3 validation leads working on a special project for the rest of this year which is focused on "e-record & E-signature, risk assessment, and 21 CFR Part11"

Job Responsibilities:

  • Author and execute test protocols to support computer system validation
  • Follow FDA 21 CFR Part 11 regulations, GxP regulations, client policies/ procedures, GAMP5 best practices
  • Work closely and communicate with project teams/ system owners/technical teams to analyze requirements and build test protocols
  • Develop and manage GxP system lifecycle documentation, including Validation Plans, User Requirements Specifications, Functional and Design Specifications, Testing Protocols, User Acceptance Testing, Traceability Matrix, Validation Reports
  • Develop test plans
  • Documentation
  • Manage and coordinate all aspects of the computer systems validation activities as they pertain to SDLC, including project planning, developing validation strategies, document development and document reviews
  • Communicate issues that could impact scope or timeline to validation team leadership
  • Perform training in ISOtrain.
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