Supplier Qualification Manager

Vor 4 Tagen


Zug, Schweiz Skilled Recruitment Solutions GmbH Vollzeit

Hauptaufgaben:

  1. Verwaltung und Überwachung der Qualifikation von Lieferanten unter Einhaltung der GMP-Standards und der Qualitätsanforderungen
  2. Bearbeitung und Lösung von Feststellungen aus Lieferantenaudits, einschließlich Abweichungen, die während Inspektionen durch Swissmedic oder andere Aufsichtsbehörden festgestellt wurden
  3. Zusammenarbeit mit Lieferanten, um die Einhaltung von Qualitätsvereinbarungen und Standards für Arzneimittel (Drug Products, DP), die von Viatris in der Schweiz vertrieben werden, sicherzustellen
  4. Durchführung von Risikoanalysen im Zusammenhang mit der Lieferantenqualität und Implementierung effektiver Risikomanagementstrategien
  5. Pflege einer genauen und aktuellen Dokumentation zu Lieferantenqualifikationen und Audits in den Systemen Trackwise und SAP
  6. Enge Zusammenarbeit mit internen Stakeholdern, darunter Regulatory-, Compliance- und Operation-Teams, um die Lieferantenqualitätsmanagementpraktiken abzustimmen
  7. Unterstützung im externen Qualitätsmanagement, einschließlich 3rd-Party-Risikomanagement und Lieferantenaudits

Qualifikationen und Erfahrung:

  1. Mindestens 5 Jahre Erfahrung in der Lieferantenqualifikation in einem GMP-regulierten Umfeld
  2. Nachgewiesene Expertise in Qualitätsmanagementsystemen, Lieferantenaudits und der Bearbeitung von Abweichungen
  3. Vertrautheit mit den Systemen Trackwise und SAP ist erforderlich
  4. Fundierte Kenntnisse in QA-Compliance, Risikomanagement und regulatorischen Anforderungen
  5. Kenntnisse in GDP-Praktiken und Swissmedic-Vorschriften sind ein starker Vorteil
  6. Hervorragende Problemlösungsfähigkeiten und hohe Aufmerksamkeit für Details
  7. Starke Kommunikations- und Teamfähigkeiten für die effektive Zusammenarbeit mit interdisziplinären Teams und externen Lieferanten
ERP Analyst/Consultant für Supply Chain Management (m/w/d)

Risch-Rotkreuz, Zug, Switzerland 1 day ago

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