This Job Vacancy has Expired!

CSV Expert (QA & Validation)

Posted on Oct 8, 2019 by NextLink Solutions

Basel, Switzerland
Immediate Start
Annual Salary

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

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 ( 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;


Reference: 769250676

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