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Senior Label Specialist, System and Processes

2 months ago

Hamilton, Ontario, Canada Allergan Full time
Jobbeschreibung

Wir suchen nach einer engagierten Person, die mit uns die gesundheitlichen Herausforderungen von morgen anzugehen und die Lebensqualität von Patient*innen zu verbessern.

Hauptrollen und Verantwortlichkeiten
  • Erstellung von Etikettendesigns und Abstimmung von Etikettenübersetzungen in Übereinstimmung mit den Vorgabedokumenten auf globaler und lokaler Ebene
  • Überprüfung der Etikettentexte auf GMP-Konformität und Freigabe der Masterlabel und Studienetiketten mit der Prüfmusterbereitstellungssoftware
  • Genehmigung der Master-Textphrasen nach den EDQM-Standard Terms
  • Koordination, Durchführung, Dokumentation und Genehmigung der Änderungen von Phrasen-Übersetzungen in den entsprechenden QM-Systemen und TRACK
  • Planung und Organisation der Etikettendesignaufträge
  • Kommunikation mit externen und internen Geschäftspartnern, z.B. klinischen Teams, dem Projektmanagement und der Qualitätssicherung
  • Weiterentwicklung von Konzepten sowie Implementierung neuer Prozesse zur Verbesserung der Abläufe der funktionsspezifischen Tätigkeiten auf lokaler und globaler Ebene
  • Selbständige Erstellung von Vorgabedokumenten, z.B. Arbeitsanweisungen, zu den funktionsspezifischen Tätigkeiten
  • Verantwortung für den Inhalt von Abweichungsberichten und von geplanten Abweichungen, für die Festlegung und Umsetzung von Korrektur- und/oder Kontrollmaßnahmen
Qualifikationen
  • Pharmaziestudium mit Approbation zum/zur Apotheker/-in
  • Erste Berufserfahrung in der Entwicklung, Herstellung oder Qualitätskontrolle von Arzneimitteln, im Projektmanagement für die Durchführung klinischer Studien oder in der Zulassung von Arzneimitteln
  • Hohes Maß an Teamfähigkeit und sehr gute kommunikative Fähigkeiten
  • Sehr gute Deutsch- und Englischkenntnisse in Wort und Schrift
Unser Angebot
  • Abwechslungsreicher Tätigkeitsbereich mit Möglichkeiten, wirklich etwas bewegen zu können
  • Offene Unternehmenskultur
  • Attraktive Vergütung
  • Intensive Einarbeitung durch eine*n Mentor*in
  • Flexible Arbeitszeitmodelle für eine gesunde Work-Life-Balance
  • Betriebliches Gesundheitsmanagement mit umfassenden Gesundheits- und Sportprogrammen
  • Betriebliche Sozialleistungen
  • Vielfältige Karriereoptionen in einem international aufgestellten Unternehmen