Senior CSV Specialist ? Digital Health

  • 14 June
  • Kanton Basel-Landschaft
  • Interim
For our client, a leading Life Sciences company with headquarters in the Basel area, Swisslinx are searching for a highly motivated Senior CSV Specialist to join their R&D department specifically within the area of digital health for a 5 month contract

Senior CSV Specialist ? Digital Health

Tasks and Responsibilities include:
Integrate a project team working in the fast pace area of Digital Health
? Liaison between business and development team
? Create or support the creation of project based documentation for computerized systems validation:
? Creating risk assessments, validation plans and reports.
? Collect user requirements
? Write functional specifications
? Deliverables of the Specify and Design Phase
? Create or support the creation of User Guides, Admin Guides
? Responsible for reviewing (formally or informally) CSV deliverables:
? Review design specs and make sure they cover requirements
? Review System Test + UAT scripts, liaise with test team
? Lead and coordinate testing activities:
? Plan and monitor SAT and UAT with testers and users
? Support and coordinates SAT and UAT, as required
? Ensure requirements traceability
? Support IT and Quality while discussing CSV strategy
? Providing validation and Compliance advice and guidance to project managers and project team.

What to bring:
? +7 years of experience with computer systems validation (CSV) projects and all related deliverables
? +7 years of experience with computer system and device qualification
? 1-2 years of experience in mobile application development and/or validation
? Extensive technical background (+10 years? experience in the Informatics/Information Management area) and Software Development Lifecycle
? Extensive knowledge of the full Lifecycle of an Information Management (IM) project and supporting a project methodology
? Good and up-to-date knowledge of medical device regulatory framework
? Flexible and able to work on several tasks in parallel
? Team player with very good communication skills
? Excellent written and spoken English language skills

This position offers a fantastic opportunity for a candidate to gain experience with one of the world?s leading life sciences companies.

Would you like to learn more about this unique opportunity? Then please apply online. We look forward to hearing from you!