Beschreibung
We are looking for a CSV Expert to support the development of the EDISON (Enlightened
Data Integration Solution) Platform, which addresses the root causes of low data quality by
harmonizing, automating and integrating the process in which clinical biomarker data is acquired and
integrated.
General information:
• Start date: 15.10.2019
• Latest start date: 31.12.2019
• End date: 31.12.2020
• Extension: An extension is planned, but needs to be approved
• Work load: 100%
• Work location: Basel
Tasks & Responsibilities:
• Drive the move to an agile regulatory framework
• Create or support the creation of project based documentation for computerized systems validation:
• Create risk assessments, validation plans and reports.
• Write functional specifications
• Deliverables of the Specify and Design Phase
• Registry list
• 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
• Responsible for monitoring CSV deliverables (all project phases)
• Lead and coordinate testing activities:
• Plan and monitor SAT and UAT with testers and users
• Support and coordinates SAT and UAT, as required
• Review executed SAT and UAT, management of the deviation log
• Ensure requirements traceability
• Support IT and Quality while discussing CSV strategy
• Providing validation and Compliance advice and guidance to project managers and project team.
Must Haves:
• +7 years of experience with computer systems validation (CSV) projects and all related deliverables****
• +7 years of experience with computer system and device qualification ****
• Extensive technical background (+10 years’ experience in the Informatics/Information Management area) and Software Development Lifecycle ****
• Experience with HP ALM, Jira and confluence****
• Extensive knowledge of the full Lifecycle of an Information Management (IM) project and supporting a project methodology ****
• Flexible and able to work on several tasks in parallel
• Team player with very good communication skills
• Excellent written and spoken English language skills
Nice to Haves:
• Experience of internal CSV guidelines and processes
• Experience in the Pharmaceutical industry
Preferred industry background;
Pharma