Beschreibung
Senior Validation Expert - Digital Biomarkers Program - CSV / SDLC / Risk Assessments / Information Management / MedicalProject / Role: For our customer, a renowned pharmaceutical company in Switzerland, we are looking for an Approved Validation Expert. The role is contract position initially for 5 months (with strong possibility of extension) in Basel Switzerland.
Main tasks:
-Integrate a project team working in the fast pace area of ??Digital Health
-Leaise 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
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 traceability requirements
-Support IT and Quality while discussing strategy CSV
-Provide validation and compliance advice and guidance to project managers and project team
Requirements:
-Should have around 7 + years of experience with CSV projects and all related deliverables.
-Should have around 7 years of experience with computer system and device qualification
-Must have 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.
-Must have extensive knowledge of the full Lifecycle of Information Management (IM) project and supporting a project methodology
-Good and up-to-date knowledge of mobile health regulatory framework
-Should be flexible and able to work on several tasks in parallel.
-Should be a good team player with very good communication skills.
Nice To Have:
-Experience of clients CSV guidelines and process experience in the Pharmaceutical industry.
-Experience in Medical Device
-Certification process
Education: University degree / Master of Science in Mechanical Engineering, Mechatronics, Micromechanics or a related discipline or relevant area of ??study and / or equivalent professional experience.
Languages:
* English - Fluent
* English - Fluent (Nice to Have)
Reference No .: 918212NC
Role: Senior Validation Expert - Digital Biomarkers Program
Industry: Medical
Location: Basel and Region
Workload: 100%
Start: ASAP
Duration: 30.09.2019 (with possibility of extension)
Should you find yourself suitable for this position, please send us your complete CV using the link in this advert. Directly, you can send us your CV anyway via this advert or at jobs [at] itcag [dot] com.
About us: ITech Consult is a certified ISO 9001: 2008 Swiss company with offices located in Germany and Ireland. ITech Consult is specialized in delivering IT candidates for contract work. We were founded in 1997 by IT professionals; thus we understand what it means to be professionally supported in your search for a new project and being employed.