IT Quality Manager
vor 4 Wochen
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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