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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