Accessibility Links
Unter Zeitdruck? Schicken Sie uns Ihren Lebenslauf in nur 2 Minuten!
     
Unter Zeitdruck? Schicken Sie uns Ihren Lebenslauf in nur 2 Minuten!
Close

Senior Validation Expert

  • Gehalt: CHF90 - CHF100 per hour
  • Art der Stelle: Contract, Full-time
  • Ort: Basel
  • Berufsbereich: Mobile Development, Other, Software Development
  • Datum der Ausschreibung: 29.03.2019
  • Job ID: BBBH97771

Senior Validation Expert

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

One of the biggest international pharmaceutical companies is looking for a Senior Validation Expert. This is a challenging contracting position starting at the beginning of March for 6 months in Basel, Switzerland.

Summary

My client's Research and Development Informatics team is the bridge between digital technology and science. They help drive medical innovation and are integral to the realization of truly Personalized Healthcare and the development of innovative treatments for patients.
Their objective is to use digital biomarkers to make their clinical development programs even more successful.

Your 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 coordinates 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.

What you must have

  • +7 years of experience with CSV projects and all related deliverables
  • +7 years of experience with computer system and device qualification
  • 1-2 years of experience in mobile application development and/or validation
  • Extensive technical background (+10 years of experience in the Informatics/Information Management area) and Software Development Lifecycle
  • Extensive knowledge of the full Lifecycle of an Information Management (IM) project and supporting a project methodology
  • Good and up-to-date knowledge of mobile health regulatory framework
  • Flexible and able to work on several tasks in parallel
  • Team player with very good communication skills
  • Excellent written and spoken English language skills

What is nice to have

  • Experience of CSV guidelines and processes
  • Experience in the Pharmaceutical industry
  • Experience in Medical Device certification process

Overview

  • Start date: 15.04.2019
  • End date: 31.10.2019
  • Work location: Basel
  • Workload: 100%

Interested in this opportunity? Kindly send us your CV today through the link in the advert. However, should you have any questions please contact Alexander Russell on +41 61 282 22 16, at www.linkedin.com/in/alex-russell-experis/ or via email

To view more jobs in Basel, visit https://www.experis.ch/it-jobs-in-basel

Änliche Jobs
ViewMoreSimilarJobs * DEFAULT * de-DE