Beschreibung
Are you looking for an interesting and challenging opportunity in Switzerland.
Next Link is looking for a Computer Systems Validation Expert (Algorithm Validation) - Digital Biomarkers to work in Basel, Switzerland for a 9 month contract(possible extension) for a multinational client.
Next Link Solution, a Swiss IT Consultancy Company that has been providing both IT services and IT staffing to major customers for the past 20 years, has an excellent opportunity that can take your career to the next level.
Please feel free to pass this information on to anyone who you think would be a good match for this role.
General information:
Job Title: Computer Systems Validation Expert (Algorithm Validation) - Digital Biomarkers
WorkLoad: 80%
Location: Basel, Switzerland
Duration: 9 months
Deadline to respond: Before 1:30 PM CET 7th August OR ASAP
Must Haves:
Expertise with computer systems validation (CSV) projects and all related deliverables (preferred also in kick starts)
Ability to understand and document data analysis methods and algorithms - scientific or engineering background
Expertise in computer systems and device qualification, ideally Cloud environment
Experience in regulated software development processes within the Pharmaceutical or other regulated industry
Expertise in modular software development for ease of code reuse
Technical background with experience in the Informatics/Information Management area and Software Development Lifecycle
Experience in agile software development methodology (SCRUM preferred)
Excellent written and spoken English language skills
Nice to Haves:
Experience of pharma internal CSV guidelines and processes
Experience in using HP Application Lifecycle Management (HP ALM)
Expertise in hands-on mobile software development
Experience in coaching software developers
Experience in Python
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 coordinate 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.