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Quality Assurance Manager

vor 3 Monaten


Frankfurt am Main, Hessen, Deutschland FERCHAU GmbH Vollzeit

Menschen und Technologien verbinden. Den Perfect Match für unsere Kunden gestalten. Immer die richtigen Expert:innen für die jeweilige Herausforderung finden - das ist unser Anspruch bei FERCHAU und dafür suchen wir Sie: als Mitarbeiter:in für einen unserer Kunden. Wir realisieren spannende Projekte für namhafte Kunden in den Bereichen Pharma und Life Science und überzeugen täglich mit fundierter Expertise und fachlichem Know-how. Sie möchten Ihr Potenzial vollständig entfalten können? Wir bieten Ihnen eine Umgebung mit vielfältigen Aufgaben, neuen Herausforderungen und permanenten Chancen, an denen Sie weiterwachsen und Ihr Profil schärfen können.

Quality Assurance Manager (m/w/d) Pharma

Diese Herausforderungen übernehmen Sie

  • Etablierung und Weiterentwicklung von FDA, EU GMP, ICH-konformen Q-Systemen
  • Erstellung von Abweichungsberichten, CAPAs, Change Controls
  • Verantwortung für die Qualifizierung und Validierung und die Pflege sowie Ausbau des Training-Systems
  • Erstellung, Auswertung und Analyse von Key Performance Indicators
  • Vorbereitung, Durchführung und Nachbereitung von Audits und Inspektionen
  • Management von Gap-Assessment-Prozessen
  • Kontinuierliche Bewertung von nationalen und internationalen Gesetzen und Richtlinien sowie die Umsetzung von Vorgaben der Bereiche des Qualitymanagements in lokale Prozesse
  • Enge Zusammenarbeit mit der Zulassungsabteilung und anderen Standorten

Das erwartet Sie bei uns

  • Betriebliche Altersvorsorge
  • Satte Rabatte mit Einkaufsvergünstigungen, z. B. bei Reisen, Elektronik oder Autos
  • Sonderurlaub für wichtige private Anlässe, z. B. Hochzeit, Umzug, Geburt
  • Urlaubsgeld nach Tarifvertrag
  • Weiterbildungsangebote unseres Inhouse-Instituts, der ABLEacademy (E-Learnings, Trainings und Seminare)

Das bringen Sie mit

  • Erfolgreich abgeschlossenes Studium in den Bereichen Chemie, Pharmazie, Biologie, Biotechnologie oder vergleichbar
  • Mehrjährige Berufserfahrung im Umfeld der Qualitätssicherung in einem produzierenden Unternehmen der pharmazeutischen Industrie wünschenswert
  • Umfangreiche Kenntnisse im FDA-regulierten Bereich
  • Erfahrung im Bereich Herstellung, Qualitätskontrolle oder Qualitätssicherung von APIs
  • Hohes Verantwortungsbewusstsein und Zuverlässigkeit
  • Ausgeprägte Analyse- und Bewertungsfähigkeit sowie Prozess- und Qualitätsorientierung
  • Gute Englischkenntnisse in Wort und Schrift

Lust auf die nächste Herausforderung? Dann sollten wir uns unbedingt kennenlernen Am schnellsten geht es, wenn Sie sich direkt bewerben - gerne online unter der Kennziffer XI F bei Frau Tamara Wurdak. Lassen Sie uns gemeinsam das nächste Level nehmen und Technologie nach vorne bringen