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.