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Quality Assurance Manager (m/w/d)
Als Mitabeiter (m / w / d) der Abteilung Qualitätssicherung unterstützen Sie das Team bei der Aufrechterhaltung und Weiterentwicklung des Qualitätsmanagementsystems nach GMP-Richtlinien.
Ihre Hauptaufgabe wird die Bearbeitung von Abweichungen, Änderungskontrollen und CAPAs in Zusammenarbeit mit den anderen Fachabteilungen sein.
Darüber hinaus werden Sie innerhalb des Dokumentenmanagementsystems SOPs schreiben, Dokumente überprüfen, in Kraft setzen und abschließend archivieren.
Weiter werden Sie im Bereich Quality KPIs entsprechende Datenerhebungen durchführen und vorstellen. Ihre Unterstützung wird beim Batch Record Review erforderlich sein und Sie werden entsprechend Ihrer Expertise Schulungen durchführen und verwalten (Trainingsmanagementsystem).
Erfolgreich abgeschlossenes Studium in den Bereichen Biotechnologie, Molekularbiologie, Pharmazie oder vergleichbarMehrjährige Berufserfahrung im Umfeld der Qualitätssicherung in der pharmazeutischen Industrie Kenntnisse und Erfahrung mit Qualitätssystemen in einer regulierten Umgebung (EU-GMP, ICH, etc.
Selbständige, systematische Arbeitsweise und die Bereitschaft, Verantwortung zu übernehmenDeutsch und Englisch sehr gut in Wort und Schrift
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