Beschreibung
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.
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 Roche 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