Beschreibung
Senior Validation Expert - Digital Biomaker - CSV - Mobile Application - Software Development - Pharmaceuticals - English - Switzerland
NextLink is having an existing position as a Senior Validation Expert for global projects in Switzerland for our core client within Pharmaceutical industry.
General information:
- Start date: 01.03.2019
- End date: 30.09.2019
- Extension: An extension might be possible, but would need to be approved.
- Work location: Basel,
- Workload: 100%
- Travelling: Not required.
- Team size: 20 team members
Your main accountabilities will be:
* 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.
Requirements:
* +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 ( 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
Nice to Haves:
+++ Experience in the Pharmaceutical industry
+++ Experience in Medical Device certification process
Call Samuel or send me your most up to date CV on: (see below)