Senior Documentation Engineer – Primary Packaging

vor 1 Woche


Bern, Schweiz Hays Vollzeit

Senior Documentation Engineer – Primary Packaging & Medical Devices (m/w/d) Freiberuflich/in temporärer Festanstellung für ein Projekt Bern Startdatum: sofort Referenznummer: /1 Diesen Job teilen oder drucken Aufgaben Unterstützung bei Auswahl, Qualifikation und Implementierung von neuen sowie bestehenden Primärverpackungsmaterialien, Medizinprodukten und Kombinationsprodukten  Pflege und Aktualisierung der Design History Files (DHF) für Bestandsprodukte  Sicherstellung der Einhaltung regulatorischer Standards (ISO 13485, 21CFR820, ISO 14971, EU MDR)  Erstellung, Prüfung und Freigabe von Design Control Dokumenten (z. B. Verifikations- und Validierungsprotokolle, Risikomanagementpläne, Änderungsmanagementpläne)  Zusammenarbeit mit den Abteilungen Regulatory, QA, Fertigung und Supply Chain zur Steuerung von Designänderungen und Compliance-Projekten  Analyse von Produktbeschwerden und Durchführung von Root Cause Analysen Profil Einschlägige, profunde Erfahrung in der Entwicklung von Medizinprodukten im pharmazeutischen Umfeld  Fundierte Kenntnisse im Change Control, Post-Market Surveillance sowie CAPA-Prozesse  Nachweisliche Erfahrung im Lifecycle Management und der kontinuierlichen Verbesserung bestehender Produkte  Hervorragende organisatorische und kommunikative Fähigkeiten; selbstständiges Arbeiten  Wissenschaftlicher Hintergrund im Bereich Primärverpackung und Arzneimittelabgabesysteme  Erfahrung in Design Control Dokumentation, Risikomanagement und SOP-Erstellung  Fließende Deutschkenntnisse, Englischkenntnisse auf muttersprachlichem Niveau Benefits Mitarbeit in einem strategisch wichtigen und dynamischen Projektumfeld



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