CSV/Validation Specialist
Princeton, New Jersey
Posted on: July 27, 2021
Industry: QA Testers
Job Number: JN -072021-67622
Review computerized systems validation documents such as:
- Requirements Specification
- Design Specification
- CSV Risk Assessment
- Test Plans
- Test Summary Reports
- Data Migration Plan
- Pre/Post Executed Test Scripts
- Traceability Matrix
- Release to Production Statements
- Direct and review testing
- Provide guidance on quality issues that affect the integrity of the data or the system
- Obtain and respond to QA review
- Participate in establishing standard quality and validation practices
- Independently assess compliance practices and recommend corrective actions
- Approve validated computer system related change requests
- Monitor regulatory and inspection trends and advise the business on suitable action
- Ability to create documents to an existing document standard.
- Able to develop all documentation required for a 21 CFR Part 11 validated project, including Validation Plans and Summaries.
- Advanced knowledge of complete MS Office suite and Visio. Firm understanding of technology platforms as needed for project.
- Experience with electronic document management systems (e.g., documentum, Qumas, SharePoint etc.); application development and lifecycle management (e.g., HP ALM, JIRA, etc.); and IT service management systems (e.g., ServiceNow, SAP Solution Manager, etc)
- Excellent oral and written communication skills in English. Strong expertise and ability to interview and accurately interpret communication requirements of team members.
- Once trained, have the ability to work independently on CSV projects with minimal oversight.