CSV/Validation Specialist

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.