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Validation Analyst


7 Years of experience as Quality/Validation Analyst is preferred 

1
Skills/Experience
  • Author and execute test protocols to support computer system validation
  • Follow FDA 21 CFR Part 11 regulations, GxP regulations, AbbVie policies/ procedures, GAMP5 best practices
  • 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
  • Author, execute and perform quality checks on test scripts using HP Quality Center
  • Document bugs/defects using HP Quality Center
  • Work closely and communicate with project teams to analyze requirements and build test protocols
  • 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
  • Relies on experience and judgment to plan and accomplish goals
  • Is detail oriented
  • Performs a variety of tasks
  • Works under general supervision; typically reports to a manager
  • Requires a bachelors degree and 4-7 years of experience

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