Regulatory Affairs Manager
vor 11 Stunden
Die AlphaConsult Gruppe ist ein Experte für hochwertige Personaldienstleistungen für mittelständische Unternehmen. Als Teil der Gruppe ist die AlphaConsult Premium KG auf die Bedürfnisse unserer Kunden spezialisiert und bietet ein umfangreiches Leistungsportfolio mit ganzheitlichen Lösungskonzepten und umfassender Personalberatung an.
Die RolleWir suchen einen Regulatory Affairs Manager, der unsere Kunden bei der Umsetzung von Validierungs- und Qualifizierungs-Prozessen unterstützt. Der Kandidat sollte über ein abgeschlossenes technisches Studium (Medizintechnik, Biotechnologie oder vergleichbar) verfügen und gute Kenntnisse über Validierung / Qualifizierung in einem Medizintechnikunternehmen haben.
Aufgaben- Planung und Durchführung von Prozessvalidierungen (intern/extern)
- Mikrobiologische Überwachung von Produkten nach Kundenspezifikation
- Planung und Betreuung von Qualifizierungen
- Betreuung von FMEAs
- Erstellung und Aktualisierung von Vorlagen für Validierungen und Qualifizierungen
- Auditbetreuung hinsichtlich Validierung / Qualifizierung / Hygienische Überwachung
- Prüfung und Freigabe von Prüfprotokollen von externen Dienstleistern
- Nachverfolgung internationaler regulatorischer Anforderungen hinsichtlich Validierung / Qualifizierung
- Erstellung und Weiterentwicklung von Verfahrensanweisungen
- Gute Bezahlung
- Mitarbeiterangebote
- Tagschicht
- Premiumjob
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