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CSV (Computer Systems Validation) Expert

Posted on Oct 8, 2019 by Experis AG

Basel, Switzerland
IT
21 Oct 2019
Annual Salary
Contract/Project

CSV (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 Computer Systems Validation Expert with experience in Software Development Lifecycle.

This is a challenging contracting position starting in October until the end of 2020 with extension possibilities.

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

Requirements:

  • +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 eg. years' experience in the Informatics/Information Management area) and Software Development Lifecycle
  • Experience with HP ALM, Jira and confluence
  • Flexible and able to work on several tasks in parallel
  • Team player with very good communication skills
  • Excellent written and spoken English language skills
  • Experience in the Pharmaceutical industry

Location: Basel

Start Date: 21.10.2019

End date: 31.12.2020

Extension: possible

Work location: Basel

Workload: 100%

Remote/Home Office: possible 1 day per week

Travelling: Some business trip

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!

Reference: 769257721

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