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Working with the Infrastructure and Hosting Services (IS) teams (Company and Enterprise Service Providers) to assess upcoming infrastructure components installations (server, DB and storage), assess application tool installations and upgrades, and execute the qualification process as applicable, ...

Job Description

  • Working with the Infrastructure and Hosting Services (IS) teams (Company and Enterprise Service Providers) to assess upcoming infrastructure components installations (server, DB and storage), assess application tool installations and upgrades, and execute the qualification process as applicable, ensuring change requests are submitted per company policy
  • QA review and approval of related change tickets
  • Ensure any deviations are documented, remediated, and closed
  • Track and ensure qualified assets have an appropriate disposition
  • Ensure the qualification of infrastructure software or applications that interface/impact GxP applications
  • Ensure qualification documentation is efficiently managed and available for inspection
  • Participate in the implementation of the vitalize (ServiceNow) – AWS Connector
  • Design and test new workflow to introduce qualification automation, while still meeting qualification requirements
  • Test, document and implement the digitalization of the application qualification process within the ServiceNow (vitalize) change ticket
  • Participate in status calls representing IT Quality Management
  • Serve as a qualification subject matter expert
  • Maintains close communication with stakeholders and team members to keep apprised of status and timelines
  • Reports status to management
  • Assist in the preparation of summary reports

Qualifications:

  • Degree in computer science, information technology, life science or 5 years-experience in software quality assurance in the life sciences industry
  • Technically conversant in infrastructure 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
  • Open to creative, innovative, flexible and practical approaches to improving practices and solving problems