Senior Validation Expert - Digital Biomarkers

Vor Ort
6 months +
Next Link Solutions
flag_no Schweiz

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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: End date: 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.


* +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

Nice to Haves:

+++ Experience in the Pharmaceutical industry +++ Experience in Medical Device certification process

Call Samuel on: or send me your most up to date CV on: