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Quality Specialist

vor 4 Monaten

Göttingen, Deutschland NextPharma Vollzeit
Quality Specialist / Field QA (m/w/d) Standort:

Goettingen, NI, DE, 37081

Berufsfunktion: Qualitätssicherung Startdatum: ab sofort Arbeitszeit: Vollzeit Sie suchen...

nach einer spannenden beruflichen Herausforderung? Wir sind einer der führenden, europäischen Auftragshersteller im Bereich der Pharmazeutischen, Biotech- und Health Care-Industrie mit rund 2.200 Kolleginnen und Kollegen in Deutschland, Frankreich, England, Finnland und Norwegen. Für uns ist der wichtigste Schritt immer der Nächste. Denn Schnelligkeit treibt uns an, erfüllt unsere Arbeitswelt mit Dynamik und lässt uns wachsen. Unser bestes Rezept für gemeinsamen Erfolg: Raum für Passion. Denn wir sind uns sicher: Wo exzellenter Service weltweit begeistert, ist Leidenschaft die beste Medizin. Willkommen in der Arbeitswelt von NextPharma.

Zur Verstärkung unseres NextPharma Teams in Göttingen suchen wir ab sofort eine/n:

Quality Specialist / Field QA (m/w/d)

Das Aufgabengebiet im Überblick:

  • Aufrechterhaltung der GMP-Anforderungen für die Herstellung von Arzneimitteln.
  • Um die Grundsätze der "QA Field" zu implementieren, führen Sie die Routineaufgaben wie folgt durch:
  • Vor-Ort-Kontrollen und Spot Checks während der Herstellung, Lagerung im Produktionsbereich.
  • Das Bindeglied zwischen Herstellungsabteilung und Qualitätsabteilung bei der Übertragung von qualitätsrelevanten Fragestellungen.
  • Unterstützung bei der Bearbeitung und Dokumentation von Abweichungen in der Produktion und Verpackung
  • Bearbeitung und Dokumentation von Kundenreklamationen.
  • Unterstützung der Herstellungsleitung bei der Erarbeitung und Implementierung von SOPs und Arbeitsanweisungen im Zusammenhang mit den im Vorfeld genannten Aufgaben
  • Durchführung von Schulungen für das Personal in Übereinstimmung mit definierten SOPs, Betriebsanweisungen und Herstellprotokollen
  • Unterstützung bei der Vorbereitung von Behördeninspektionen (lokale, FDA und andere Zulassungsbehörden) und Kunden-Inspektionen

Was bieten wir Ihnen?

  • Passgenaues On-Boarding

  • 37,5 Stunden-Woche & Tarifliche Vergütung

  • 30 Urlaubstage, Urlaubsgeld & Jahresleistung

  • Betriebliche Altersvorsorge und Pflegezusatzversicherung

  • Mitarbeiter-Events und betrieblicher Sport

  • Weiterbildungen bei der internen NextAcademy

  • Mitarbeiter-Rabatte

Ihr Profil:

  • Naturwissenschaftlicher Hochschulabschluss / Apotheker
  • Erfahrung in der pharmazeutischen QA / Produktionsumgebung wünschenswert
  • Erfahrungen im Umgang mit GMP sowie den aktuellen Gesetzen und Verordnungen
  • Selbständigkeit, Zuverlässigkeit, Kommunikations-fähigkeit und Verantwortungsbewusstsein
  • Sehr strukturierte, sorgfältige und präzise Arbeitsweise
  • Gute Englischkenntnisse in Wort und Schrift sowie sicherer Umgang mit MS Office
  • Fließende Englischkenntnisse in Wort und Schrift

  • Gute MS Office-Kenntnisse (insbesondere Excel, Word)

It's time for your next chapter:

Wir freuen uns auf Ihre Bewerbung.

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