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Experte für GMP-Produktionsdienstleistungen

vor 2 Monaten


Penzberg, Bayern, Deutschland headwaypersonal GmbH Vollzeit
Beschreibung der Position

Wir suchen einen erfahrenen Senior Specialist GMP Services für unsere Kunden in Penzberg. Die Position ist Teil unseres Teams für GMP-Dienstleistungen und erfordert eine hohe Qualifikation und Erfahrung im Bereich der Produktion und Qualitätssicherung.

Aufgaben und Verantwortlichkeiten
  • Bearbeitung von Risikoanalysen und Entwicklung von Strategien zur Risikominderung
  • Funktion als Owner für Abweichungen und Risikoanalysen: Verantwortung für die termingerechte Planung, Koordination und Umsetzung von Events
  • Koordination der Schnittstellen zwischen verschiedenen Abteilungen, wie z.B. Produktion, MSAT und Qualitätssicherung
  • Funktion als Experte in den geltenden internen GMP-Standards zur Sicherstellung der korrekten Darstellung der Herstelldokumentation
  • Mitarbeit bei der kontinuierlichen Optimierung und Standardisierung des QRM/Abweichungsprozesses
Anforderungen und Qualifikationen
  • Abgeschlossene Ausbildung zum/zur Techniker/in Chemie, Biotechnologie o.ä. oder ein Studium mit technischem oder naturwissenschaftlichem Schwerpunkt (bspw. Biotechnologie, o.ä.)
  • Fundierte Berufserfahrung im Bereich Produktion oder Qualitätssicherung im GMP-Umfeld ist zwingend erforderlich und unabdingbar
  • Starker Quality Management Hintergrund
  • Fließende Deutsch- und (mindestens) gute Englischkenntnisse
  • IT-Affinität und Fähigkeit sich schnell in neue Tools einzuarbeiten
  • Fähigkeit sich auf verschiedene Stakeholder einzustellen
  • Erfahrung mit LEAN Tools und/oder Verständnis von und Erfahrung mit KVP von Vorteil
Unser Unternehmen

Wir sind HEADWAYpersonal GmbH, ein Unternehmen der Personaldienstleistung mit über 100 Niederlassungen in 21 Ländern. Wir legen Wert auf Vielfalt und Chancengleichheit, unabhängig von Alter, Geschlecht, Behinderung, ethnischer Herkunft, sexueller Orientierung oder sozialem/religiösem Hintergrund.