Job Description :
Validation Consultant
North Chicago, IL
Video
6 month
JD
Description Details
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 ISO train
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
Minimum Requirements:
1. Pharma background
2. Requires a bachelor's degree and 4-7 years of experience
3. Understanding of GxP 21 CFR Part 11 requirements
4. Good Communication skills