For our customer located in Basel/Switzerland we are currently looking for (m/f/d) an Senior Validation Expert - Digital Biomarkers Program
- Type of placement: 6 months, external contract with possible long term extension
- Company: major Pharma company in Basel area
- Salary: level 3, please ask us for the exact rate range
(monthly all in salary levels in CHF, level1= 5-10k , level2=10-15k, level3= >15k)
Pharma Research and Early Development Informatics team of our customer 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.
Our Customer is shaping the digitalization of Pharma R&D and is growing. For our vision to come true, we need innovative, dedicated people from a wide variety of backgrounds.
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.
- Start date: 15.04.2019
- Latest start date: 06.05.2019
- 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
- Department: PXIZ (pREDi, Digital Biomarker Program)
- +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 of Roche internal CSV guidelines and processes
- +++ Experience in the Pharmaceutical industry
- +++ Experience in Medical Device certification process
Kindly be informed that our customer is located in Switzerland. Therefore only applications within the EU or candidates holding Swiss work permission are required.
The SymplyVision-Team is looking forward to receiving your application (Word file is highly appreciated).