Computer Systems Validation Expert (Algorithm Validation)

Basel  ‐ Vor Ort
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Beschreibung

Computer Systems Validation Expert

Experis IT is Europe's leading IT recruitment agency. We are dedicated to connecting talented individuals with Business opportunities across a number of professional sectors, with IT being at the heart of our operations.

For one of our clients, specialized in the pharmaceutical area with HQ in Basel, we are looking for a CSV Expert with previous experience in the pharmaceutical industry.

This is a challenging remote contracting position starting in September until the June 2021.

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 team

Must Haves:

  • Expertise with computer systems validation (CSV) projects and all related deliverables
  • 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
  • Experience in using HP Application Lifecycle Management (HP ALM) will be a plus
  • Expertise in hands-on mobile software development will be a plus
  • Experience in coaching software developers will be a plus
  • Experience in Python will be a plus

Location: Basel

Start Date:

End date:

Workload:100%

If you are a result-oriented CSV Expert currently looking for a challenging new position that applies to your skills, then we look forward to receiving your application!

Start
01.09.2020
Dauer
10 months
Von
Experis AG
Eingestellt
05.08.2020
Projekt-ID:
1953529
Vertragsart
Freiberuflich
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