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.
Requirements:
8-10+ Years of Overall IT Experience.
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. Client 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
Ability to perform in a highly matrixed organization structure.
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