Senior QA Specialist, Project Manager
Vor 5 Tagen
Lonza ist heute ein weltweit führendes Unternehmen im Bereich Life Sciences, welches auf drei Kontinenten tätig ist. Wir sind in der Wissenschaft tätig, jedoch gibt es keine Zauberformel dafür, wie wir die Arbeit angehen. Unsere wichtigste wissenschaftliche Lösung sind talentierte Mitarbeitende, die zusammenarbeiten und Ideen entwickeln, die anderen Unternehmen helfen, Menschen zu helfen. Im Gegenzug steuern unsere Mitarbeitenden ihre Karriere selbstständig. Denn ihre Ideen, ob gross und klein, verbessern die Welt. Und das ist die Art von Arbeit, an der wir Teil haben möchten.
Am Standort wird ein Senior QA Specialist, Project Manager (w/m/d) für unser Small Molecules Manufacturing gesucht. In dieser Position unterstützen Sie die Produktion in allen qualitätsrelevanten Themen. Dies beinhaltet im Wesentlichen 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. Damit sichern Sie ein effizientes, GMP konformes life cycle-management für alle Produkte in Produktion.
Im Weiteren sind Sie für folgende Aufgaben zuständig:
Kontrolle des Herstellungsverfahrens auf Übereinstimmung mit dem bei den Behörden registrierten Prozess
Verantwortlich bezüglich Einhaltung der Bestimmungen welche 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
Das erwarten wir von Ihnen:
Abgeschlossene Fach-/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
Idealerweise Erfahrung in der Nutzung von LIMS und TrackWise
Fließende Sprachkenntnisse in Deutsch und Englisch
Lonzas Produkte und Services wirken sich täglich positiv auf Millionen von Menschen aus. Für uns stellt dies nicht nur eine grosse Ehre, sondern auch eine grosse Verantwortung, dar. Wie wir unsere Geschäftsergebnisse erreichen ist für uns genauso wichtig wie unsere Erfolge selbst. Bei Lonza wird Respekt grossgeschrieben und wir schützen sowohl unsere Mitarbeiter als auch unsere Umwelt. Erfolg für uns bedeutet moralisch vertretbarer Fortschritt.
Zu Lonza kommen Menschen, die Herausforderungen annehmen und mit ihrer Kreativität im BereichLife Science neue Ideen für komplexe Problemstellungen entwickeln. Zusammen leisten wir einen Beitrag, der das Leben vieler Menschen auf der ganzen Welt verbessern kann. Dies bietet ihnen die Gewissheit und die Zufriedenheit, mit der eigenen Arbeit wirklich einen Unterschied zu machen.
Reference: R61055-
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