Product Lead

vor 4 Wochen


Steiermark, Österreich Fresenius Kabi Austria GmbH Zentrale Vollzeit

Fresenius Kabi Austria, with headquarters in Graz and a further production site in Linz, is a subsidiary of Fresenius Kabi AG, a world leading manufacturer of infusion therapy and clinical nutrition products. Fresenius Kabi Austria has 1600 employees and ranges among the top enterprises of the region.


Aufgaben
  • Primärer Ansprechpartner für alle Stakeholder (Vertragslabore, Lohnhersteller, Distributoren und Market Units) in qualitätsrelevanten Fragen
  • Implementierung von Spezifikationen, Prüfplänen und Stabilitätsplänen
  • Erstellung und Aktualisierung von Qualitätsvereinbarungen mit externen Partnern
  • Produkt-Schnittstellenfunktion innerhalb und außerhalb der Plant Graz sowie eine aktive Beteiligung an der strategischen Produkt Portfolio Entwicklung der Plant Graz
  • Produkt Controlling (Life Cycle Kosten Verrechnung an externe Auftraggeber) inkl. Angebotserstellung bzw.-revision
  • Meldung und Nachverfolgung von Changes/Abweichungen sowie Verfolgung der Umsetzung und Koordination von Aktivitäten und Untersuchungen mit externen Partnern
  • Zusammenarbeit mit externen Partnern in Bezug auf die Chargenfreigabe (Freigabedokumentation)
  • Organisation von Stabilitätsstudien (Stabilitätspläne, -berichte, -trends, Follow-up mit MAH)
  • Unterstützung bei der Erstellung von regulatorischen Dokumenten für Einreichungen/Variations, primäre Anlaufstelle für regulatorische Fragen im Zuge von Variations

Profil
  • Naturwissenschaftliches Studium oder vergleichbare naturwissenschaftliche Ausbildung
  • Berufserfahrung in qualitätsrelevanten Funktionen in der pharmazeutischen Industrie von Vorteil
  • Proaktive, selbstständige und strukturierte Arbeitsweise
  • Gutes Verständnis von GxP Regularien und "Best Practice in Quality"
  • Sehr gute MS Office- und Englisch-Kenntnisse
  • Exzellente Kommunikationsfähigkeit, Konfliktfähigkeit und starke Teamorientierung

Wir bieten
  • Sehr abwechslungsreiches Aufgabengebiet
  • Fortbildungsmöglichkeiten und persönliche Weiterentwicklung innerhalb des Unternehmens
  • Karrieremöglichkeiten in einem internationalen Pharmakonzern
  • Attraktive, leistungsorientierte Vergütung (Monatsbruttogehalt mind. Eur. 3.600,- Überzahlung je nach Qualifikation)

We are caring for our employees


JBG81_AT



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