Computer Systems Validation Expert (m/w/d)

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One of the biggest health care company is in the need of a CSV Expert. For this reason, we are looking for a talented professional, who is willing to be a part of this project. General Information:Start date: 01.09.2020Duration: 30.06.2021Extension: possibleWorkload: 80-100%Work location: Basel areaRemote: max. 1 day per week under regular circumstances Tasks & Responsibilities Integrate a project team working in the fast pace area of Digital HealthLiaison between business and development teamCreate project based documentation for computerized systems validation:Risk assessments, validation plans and reports.User requirementsFunctional specificationsUser Guides, Admin GuidesOther deliverables of the Specify and Design Phase as defined in the validation planResponsible for creating and / or reviewing (formally or informally) CSV deliverablesReview design specs and make sure they cover requirementsReview System Test + UAT scripts, liaise with test teamLead and coordinate testing activitiesPlan and monitor SAT and UAT with testers and usersSupport and coordinate SAT and UAT, as requiredEnsure requirements traceabilitySupport IT and Quality while discussing CSV strategyProvide validation and Compliance advice and guidance to project managers and project Technical Skills 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 backgroundExpertise in computer systems and device qualification, ideally Cloud environmentExperience in regulated software development processes within the Pharmaceutical or other regulated industryExpertise in modular software development for ease of code reuseTechnical background with experience in the Informatics/Information Management area and Software Development LifecycleExperience in agile software development methodology (SCRUM preferred)Excellent written and spoken English language skills If this outstanding opportunity sounds interesting for you, do not hesitate to contact me for more details or send me your CV.Sthree Switzerland is acting as an Employment Business in relation to this vacancy.