Qualification & Validation Consultant
Vor 4 Tagen
ABOUT ARCONDIS
Wir schaffen Mehrwert durch funktionsübergreifende, ausgefeilte Projektabwicklung und intelligente Implementierung.
Unsere Kunden lieben die Zusammenarbeit mit uns aufgrund unserer einzigartigen Fähigkeiten, unseres pragmatischen Ansatzes und unseres unbedingten Erfolgswillens. We make healthcare better.
MISSION
Tasks and responsibilities
- Costumer advice in the conception and implementation of new CSV / CSA requirements from regulated environment
- Coaching and executing in the field of all qualification (e.g. equipment...) and validation (e.g. CSV, process...) topics as well as IT compliance
STUDIES
**Profile**:
- Dependant on seniority business development is a strong plus or must-have
- Bachelors or masters degree in the field of Computer Science, Engineering, Pharmaceuticals or in a comparable field
- Very good knowledge of regulatory requirements (FDA, EU, GxP, ISO 13485) and in best practices (GAMP5)
- Several years of professional experience in the field of computerized system validation and /or qualification of hardware as well as in IT compliance topics
- Experienced with software in a production-related environment (especially MES is an advantage)
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