We are looking for a Computer System Validation specialist with experience validating Learning Management Systems. This is a remote, contract position.
- 3+ years of GxP System Validation/21CFR Part 11 within the Life Sciences field
- Experience with validation of SaaS applications
- Excellent experience with MS Office suite
- Excellent oral and written communication skills
- Solid understanding of project lifecycles and the comprehensive delivery process for GxP systems
- Ability to work independently on CSV projects with minimal oversight
- Experience with learning management systems (SuccessFactors, Saba, Sumtotal, etc.) a plus
- Experience with application development and lifecycle management tools (QC, JIRA, etc.) a plus
- Follow industry best practices for computer system validation.
- Possess expertise on GxP practices, in order to guide those within the business that are less familiar.
- Maintain close communication with stakeholders and team members to keep apprised of computerized system needs, impacts on system validation, project validation status, and other relevant issues.
- Assist in planning, implementing, and documenting user acceptance testing.
- Obtain and respond to QA review.
- Good understanding of Change Management process (preferably using ServiceNow)
- Write validation documents such as:
- Requirements Specification
- Risk Assessment
- Validation Plan and Summary Report
- Test Plans (IQ, OQ, PQ)
- Test Summary Reports
- Data Migration Plan
- Traceability Matrix