Senior Manager, Head of QC Sample Management

Vor 4 Tagen

Bern, Schweiz TN Switzerland Vollzeit

Für unseren Standort Bern, suchen wir eine(n)

Ihre Kompetenzen und Verantwortlichkeit:

Das Department QC Sample Management (QCSM) übt eine wichtige Schnittstellen-Funktion zwischen den Funktionen Logistik, Produktion sowie internen wie auch externen QC-Laboren aus.

Die Hauptverantwortung dieser Position liegt in der operativen, d.h. personellen und technischen Leitung des Departments mit rund 40 technischen und wissenschaftlichen Mitarbeitenden.

Konkret gehören folgende Aspekte dazu:

  • Sicherstellung einer cGMP-konformer Probenlogistik von Inprozess- und Endprodukt-Kontrollen
  • Verwaltung der Referenz- und Rückstellmuster sowie von Muster der Stabilitätsstudien
  • Sicherstellung einer termingerechten, effizienten Freigabe-Testung von Endprodukten nach den Regeln der cGMP (Identität und Appearance)
  • Bemusterung der Rohmaterialien
  • Probenahme im Rahmen des Umweltmonitorings von Reinräumen und deren Personal (Zonen C und D), sowie Probenahme im Rahmen des Medienmonitorings
  • Life-cycle-Management des eigenen Geräteparks
  • Planung des effizienten Einsatzes der Ressourcen (Mitarbeitende und Laborinfrastruktur)
  • Überwachung der Leistungsindikatoren des Departments
  • Sehr gute Kenntnisse des regulatorischen Umfelds (Guidelines; Pharmakopöen, etc.)
  • Unterstützung von standortübergreifenden Projekten (v.a. Lifecycle Management Projekte)
  • Ständige Weiterentwicklung der Kompetenzen und Fähigkeiten des Teams
  • Förderung eines guten Teamgeists durch aktive, offene Kommunikation

Als Mitglied des QC-Führungsteams setzen sie sich für folgende Themen ein:

  • Sie suchen nach Wegen, Prozesse zu vereinfachen, standardisieren und dadurch effizienter zu gestalten
  • Sie unterstützen die CSL Strategie bei der Priorisierung von Projekten und der strategischen Personalplanung
  • Sie sind bereit, die QC in globalen Projekten zu vertreten
  • Sie pflegen ihr fachliches Netzwerk sowohl innerhalb der Firma wie auch mit externen Fachgremien und Behörden

Qualifikationen & Erfahrung:

  • Mindestens Bachelor-Abschluss in Chemie, Mikrobiologie oder Biochemie
  • Über 7 Jahre Erfahrung im pharmazeutischen cGMP-Bereich oder ähnlichem Umfeld (GDP, Diagnostik)
  • Ausgewiesene Führungserfahrung
  • Sehr gute Kommunikationsfähigkeiten
  • Ergebnisorientiertes Arbeiten in Verbindung mit dem notwendigen Mass an Qualität und Detail
  • Erfahrung in Operational Excellence ist ein Vorteil
  • Fliessend in Deutsch und Englisch

Fühlen Sie sich angesprochen? Wir freuen uns auf Ihre Online-Bewerbung. Die Bewerbung muss ein kurzes Motivationsschreiben und ein CV-Resume beinhalten (max. 2 Seiten).

Bitte fügen Sie Ihre Dateien, inklusive CV, zu einem Dokument zusammen.

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