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Quality Specialist
vor 4 Monaten
Zur Verstärkung unseres Teams in Göttingen suchen wir ab sofort einen:
Quality Specialist / Field QA (m/w/d)
Auf dieses Aufgabengebiet können Sie sich freuen:
- 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
Das bringen Sie mit:- 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)
Sie suchen nach einer spannenden beruflichen Herausforderung?
Starten Sie bei einem führenden europäischen Auftragshersteller im Bereich der Pharmazeutischen, Biotech- und Health Care-Industrie. Mit seinen Entwicklungszentren, Produktionsstandorten sowie Lager- und Logistikstandorten ist der Konzern weltweit tätig.
Der NextPharma-Standort in Göttingen mit ca. 500 Mitarbeitern, ist innerhalb der Gruppe auf die Herstellung von festen Arzneiformen sowie die Produktion von Cephalosporinhaltigen Arzneimitteln spezialisiert. Zusätzlich werden am Standort Göttingen Dienstleistungen wie Entwicklung, Herstellung und Versand von klinischen Prüfpräparaten sowie der Mikrobiologie angeboten.
Sie sind interessiert? Wir freuen uns auf Ihre Bewerbung, die auch Ihren möglichen Eintrittstermin und Ihre Gehaltsvorstellung enthält. Bitte bewerben Sie sich auf unserer Karriereseite unter dem Link: NextPharma GmbH
Personalabteilung
z. Hd. Frau Böhmer Hildebrandstraße 10-12
37081 Göttingen
