06.09.2022 aktualisiert
100 % verfügbar
Senior Validation Consultant
Baar, Schweiz
Weltweit
Master of Arts in Business EconomicsSkills
Computer Systems ValidationRequirement Engineering21 cfr part 1121 CFR 820user requirement specificationIT-QualitySAP ValidationEU Annex 11Data IntegrityRisk Assessmentdata integrity assessmentFDAGerätevalidierungequipment validationComputerized Systems
- Unterstützung bei spezifischen Projekten in Validierungsleitung und operativer Unterstützung nach dem Lifecycle-Modell (V-Modell)
- Kenntnisse der Richtlinien und Erfahrung in der Validierung von verschiedenen Applikationen
- Templates, um eine effiziente Validierung durchführen zu können
Sprachen
DeutschMutterspracheEnglischverhandlungssicher
Projekthistorie
Validation Workstream Lead for the implementation and maintenance of the Clinical Analytics Platform:
o Operational responsibility of the computerized system
o Documentation of the business processes and standard operating procedures
o Change management, access rights and trainings management
o Data validity verification through appropriate processes and procedures
o Providing relevant documentation for audits and inspections
o Operational responsibility of the computerized system
o Documentation of the business processes and standard operating procedures
o Change management, access rights and trainings management
o Data validity verification through appropriate processes and procedures
o Providing relevant documentation for audits and inspections