Supplier Qualification Manager
Vor 4 Tagen
Hauptaufgaben:
- Verwaltung und Überwachung der Qualifikation von Lieferanten unter Einhaltung der GMP-Standards und der Qualitätsanforderungen
- Bearbeitung und Lösung von Feststellungen aus Lieferantenaudits, einschließlich Abweichungen, die während Inspektionen durch Swissmedic oder andere Aufsichtsbehörden festgestellt wurden
- Zusammenarbeit mit Lieferanten, um die Einhaltung von Qualitätsvereinbarungen und Standards für Arzneimittel (Drug Products, DP), die von Viatris in der Schweiz vertrieben werden, sicherzustellen
- Durchführung von Risikoanalysen im Zusammenhang mit der Lieferantenqualität und Implementierung effektiver Risikomanagementstrategien
- Pflege einer genauen und aktuellen Dokumentation zu Lieferantenqualifikationen und Audits in den Systemen Trackwise und SAP
- Enge Zusammenarbeit mit internen Stakeholdern, darunter Regulatory-, Compliance- und Operation-Teams, um die Lieferantenqualitätsmanagementpraktiken abzustimmen
- Unterstützung im externen Qualitätsmanagement, einschließlich 3rd-Party-Risikomanagement und Lieferantenaudits
Qualifikationen und Erfahrung:
- Mindestens 5 Jahre Erfahrung in der Lieferantenqualifikation in einem GMP-regulierten Umfeld
- Nachgewiesene Expertise in Qualitätsmanagementsystemen, Lieferantenaudits und der Bearbeitung von Abweichungen
- Vertrautheit mit den Systemen Trackwise und SAP ist erforderlich
- Fundierte Kenntnisse in QA-Compliance, Risikomanagement und regulatorischen Anforderungen
- Kenntnisse in GDP-Praktiken und Swissmedic-Vorschriften sind ein starker Vorteil
- Hervorragende Problemlösungsfähigkeiten und hohe Aufmerksamkeit für Details
- Starke Kommunikations- und Teamfähigkeiten für die effektive Zusammenarbeit mit interdisziplinären Teams und externen Lieferanten
Risch-Rotkreuz, Zug, Switzerland 1 day ago
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