Senior Quality Assurance Specialist, Project Manager
vor 3 Wochen
Lonza ist ein führendes Unternehmen im Bereich Life Sciences, das auf drei Kontinenten tätig ist. Unsere wichtigste wissenschaftliche Lösung sind hochqualifizierte Mitarbeiter, die zusammenarbeiten und Ideen entwickeln, die anderen Unternehmen helfen, Menschen zu helfen.
In der Position Senior QA Specialist, Project Manager unterstützen Sie die Produktion in allen qualitätsrelevanten Themen. Dies beinhaltet die Vorbereitung von neuen Kampagnen, die kompetente Prüfung und Kontrolle bei Änderungsanträgen, die Mitarbeit und Kontrolle bei Abweichungs- und OOS-Untersuchungen sowie das CAPA-Management.
Als Senior QA Specialist, Project Manager sind Sie für folgende Aufgaben zuständig:
- Kontrolle der Herstellungsverfahren auf Übereinstimmung mit dem bei den Behörden registrierten Prozess
- Verantwortlich bezüglich Einhaltung der Bestimmungen, die in den Qualitätsvereinbarungen mit unseren Kunden festgelegt wurden
- Zusammenarbeit mit unseren Kunden in Qualitätsthemen zur Sicherung der Erwartungen unserer Kunden
- Selbständige Prüfung der freigaberelevanten Herstellungsdokumente auf Vollständigkeit und Konformität
- Mitarbeit bei Qualitäts-Risikoanalysen und Erstellung von Quality Review Reports
- Durchführung von internen Audits sowie Mitarbeit bei Kundenaudits und Inspektionen von Behörden
Wir erwarten von Ihnen:
- Abgeschlossene Fach- oder Hochschulausbildung in Life Science (vorzugsweise im Bereich Chemie)
- Fundierte Berufserfahrung in der Pharmaindustrie, vorzugsweise im GMP-Bereich der chemischen Produktion
- Erfahrung im Management von internen und externen Stakeholdern
- Ideealerweise Erfahrung in der Nutzung von LIMS und TrackWise
- Fließende Sprachkenntnisse in Deutsch und Englisch
Bei Lonza wird Respekt großgeschrieben und wir schützen sowohl unsere Mitarbeiter als auch unsere Umwelt. Erfolg für uns bedeutet moralisch vertretbarer Fortschritt.
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