Computer Systems Validation Expert (m/w/d)

Basel  ‐ Vor Ort
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Beschreibung

One of the biggest health care company is in the need of a CSV Expert. For this reason, we are looking for a talented professional, who is willing to be a part of this project.

General Information:

Start date: 01.09.2020

Duration: 30.06.2021

Extension: possible

Workload: 80-100%

Work location: Basel area

Remote: max. 1 day per week under regular circumstances

Tasks & Responsibilities
  • Integrate a project team working in the fast pace area of Digital Health
  • Liaison between business and development team
  • Create project based documentation for computerized systems validation:
  • Risk assessments, validation plans and reports.
  • User requirements
  • Functional specifications
  • User Guides, Admin Guides
  • Other deliverables of the Specify and Design Phase as defined in the validation plan
  • Responsible for creating and / or 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 coordinate SAT and UAT, as required
  • Ensure requirements traceability
  • Support IT and Quality while discussing CSV strategy
  • Provide validation and Compliance advice and guidance to project managers and project


Technical Skills
  • Expertise with computer systems validation (CSV) projects and all related deliverables (preferred also in kick starts)
  • Ability to understand and document data analysis methods and algorithms - scientific or engineering background
  • Expertise in computer systems and device qualification, ideally Cloud environment
  • Experience in regulated software development processes within the Pharmaceutical or other regulated industry
  • Expertise in modular software development for ease of code reuse
  • Technical background with experience in the Informatics/Information Management area and Software Development Lifecycle
  • Experience in agile software development methodology (SCRUM preferred)
  • Excellent written and spoken English language skills


If this outstanding opportunity sounds interesting for you, do not hesitate to contact me for more details or send me your CV.

Sthree Switzerland is acting as an Employment Business in relation to this vacancy.
Start
08/2020
Von
Sthree Switzerland
Eingestellt
06.08.2020
Projekt-ID:
1953830
Vertragsart
Freiberuflich
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