
Head of Quality Assurance and Compliance
1 day ago
Wir suchen einen erfahrenen Head of Quality Assurance and Compliance, der sich um die Gesamtverantwortung für das Qualitätsmanagementsystem und alle GMP-Prozesse am Standort kümmert.
Als Leiter der Qualitätssicherung sind Sie verantwortlich für die Sicherstellung der Übereinstimmung aller GMP-relevanten Prozesse mit nationalen und internationalen Anforderungen sowie mit Recipharm-internen Qualitätsstandards.
Ihre Aufgaben:
- Gesamtverantwortung für das Qualitätsmanagementsystem und alle GMP-Prozesse am Standort
- Sicherstellung der regulatorischen Compliance der hergestellten Arzneimittel und deren qualifizierte Marktfreigabe in Übereinstimmung mit den GMP-Vorschriften und Zulassungen
- Aufbau und Verwaltung von robusten und optimierten Qualitätsverfahren, um eine pünktliche und effiziente Lieferung von Qualitätsprodukten zu gewährleisten
- Management und kontinuierliche Weiterentwicklung der qualitätsrelevanten Prozesse in Zusammenarbeit mit internen und externen Partnern mit dem Ziel der Effizienzverbesserung
- Enge Zusammenarbeit mit der Global Quality Unit
- Führung, Motivation und Entwicklung der Mitarbeiter Ihrer Abteilung
Ihr Profil:
- Abgeschlossenes Hochschulstudium im Bereich Pharmazie oder vergleichbare Qualifikation
- Vorzugsweise Qualifikation als Sachkundige Person/Qualified Person gemäß §14/15 AMG
- Mehrjährige Erfahrung in der Qualitätssicherung in der pharmazeutischen Industrie
- Erfahrung in der Führung von größeren Gruppen von Mitarbeitern
- Sichere Kenntnisse der nationalen und internationalen GMP-Richtlinien und Gesetze
- Analytisches Denkvermögen, strukturierte Arbeitsweise & betriebswirtschaftliches Verständnis
- Überdurchschnittliches Engagement, Durchsetzungsvermögen, Teamgeist, Organisationstalent und Kommunikationsstärke über den eigenen Bereich hinaus
- Sehr gute Englischkenntnisse in Wort und Schrift
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