- QA review and approval of related transition change tickets. Ensure any deviations are documented, remediated, and closed.
- Track and ensure all assets have a final disposition. Ensure the qualification of migration software or applications used to move GxP applications.
- Ensure qualification documentation is efficiently managed and available for inspection.
- Participate in status calls representing IT Quality Management. Serve as a qualification subject matter expert on the transition project.
- Maintains close communication with stakeholders and team members to keep apprised of project status and timelines.
- Reports project status to management. Assist in the preparation of summary reports
- Degree in computer science, information technology, life science or 5 years-experience in software quality assurance in the life sciences industry.
- Technically conversant in concepts and techniques related to servers, databases & storage devices.
- Working knowledge of GAMP5 concepts, 21 CFR Part 11 and ITIL.
- Must have change management experience, preferably ServiceNow change management experience.
- Previous experience supporting computer system validation efforts including authoring qualification deliverables.
- Strong oral and written communication skills in English. Proficiency in MS Office suite.
- Experience with electronic document management systems and testing applications such as HP ALM/HP Quality Center is a plus.
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