IT Quality Manager

vor 4 Wochen


Basel, Basel-Stadt, Schweiz Datalynx Group Vollzeit

Wir suchen einen erfahrenen IT Qualitätsmanager, der sich auf die Validierung komplexer Systemlösungen in der Life Science Industrie spezialisiert hat.

Aufgaben und Verantwortlichkeiten:

  • Konzeption, Planung und Durchführung von Computer Systems Validation (CSV) im regulierten Umfeld (Pharma, Medizinprodukte, Biotech)
  • Beratung und Unterstützung der Anwendungsverantwortlichen bei der Implementierung und der Lifecycle maintenance von GxP-konformen Systemen
  • Operative Ausführung von Validierungsaktivitäten bei CSV-Projekten
  • Evaluierung und Erstellung von GMP-konformer Dokumentation
  • Unterstützung bei der Beurteilung von CAPAs und Changes
  • Aufbau von Kundenbeziehungen und Umgang mit Kundenvertretern aus allen Funktionsbereichen

Dein Profil:

  • Hochschulausbildung in Informatik oder gleichwertig orientierte Ausbildung
  • Mindestens 5 Jahre Erfahrung im Qualitätsmanagement (ISO 900X, ISO 13485 etc.)
  • Mindestens 5 Jahre praktische Erfahrung in der Validierung von komplexen Systemlösungen - und - herstellprozessen in der Life Science Industrie nach 21CFR11, Annex11, 21CFR820 usw.
  • Erfahrung in der Zusammenarbeit von internationalen/interdisziplinären Teams
  • Erfahrung mit der Anwendung von agilen Validierungsmethoden
  • Erfahrung als Auditor von Vorteil
  • Ausgezeichnete Kenntnisse in Englisch und Deutsch
  • Starke Ausprägung von vernetztem und prozessorientiertem Denken und Handeln

Wir bieten Dir:

  • Helle und moderne Büros zentral in Basel, Nähe Bahnhof SBB
  • Sehr angenehme Arbeitsatmosphäre
  • Ein aufgestelltes und motiviertes internationales Team
  • Ein breites Projektportfolio mit vielseitigem Aufgabengebiet
  • Umfangreiche und praxisorientierte Einarbeitung
  • Selbständiges und eigenverantwortliches Arbeiten
  • Kurze Entscheidungswege durch flache Hierarchien
  • Faires Gehalt


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