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Freiburg, Baden-Württemberg, Deutschland Dr. Falk Pharma GmbH Vollzeit{"h1": "Pharmazeutische Expertise im Quality Unit", "h2": "Ihre Aufgaben", "ul": ["Kennenlernen der GMP-Prozesse innerhalb der Abteilung Quality Unit, bestehend aus Quality Control und Quality Assurance, wie z. B. CAPA, Abweichungen, Reklamationen, Lieferantenqualifizierung, Dokumentenmanagement, Stabilitätsmanagement, Validierung und Produktfreigaben",...
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Quality Control Stability Manager
vor 3 Monaten
Als Spezialist in der Verdauungs- und Stoffwechselmedizin und Familienunternehmen mit globaler Vernetzung, setzen wir unseren Fokus auf die Entwicklung und den Vertrieb innovativer Arzneimittel für verschiedene Erkrankungen der Leber, der Gallenwege, des Darms und der Speiseröhre, um das Leben von Menschen zu verbessern. Wir glauben daran,dass wir nur gemeinsam medizinischen Fortschritt erreichen können. Daher suchen wir:
Quality Control Stability Manager (m/w/d)
Aufgaben
- Sie verstärken unser Team QC Stability
- Koordination, Planung und Überwachung von Stabilitätsstudien von Arzneimitteln
- Erstellung und Pflege von Stabilitätsplänen und -berichten
- Auswertung von Daten aus Stabilitätsprüfungen und Interpretation der Ergebnisse, um Trends zu erkennen und daraus Informationen zur Produktstabilität/Haltbarkeit abzuleiten
- Bearbeitung und Bewertung von OOS/OOT-Ereignissen und Abweichungen im Rahmen von Stabilitätsuntersuchungen
- Proaktive Verbesserung von Arbeitsabläufen im Bereich Stabilitätsmanagement
- Enge Zusammenarbeit mit dem Leiter Quality Control, den Sachkundigen Personen zahlreichen internen und externen Schnittstellen (u.a. Zulassung, Entwicklung, PQR, Auftragslabors)
- Experte und Ansprechpartner für Fragestellungen im Zusammenhang mit Stabilitätsprüfungen von Arzneimitteln
Profil
- Naturwissenschaftliches Studium oder vergleichbare Qualifikation
- Mehrjährige Erfahrung in der pharmazeutischen Industrie im Bereich Qualitätskontrolle oder Qualitätssicherung(idealerweise Stabilitätsmanagement)
- Fundierte Kenntnisse der nationalen sowie internationalen GMP-Regelwerke und Guidelines für Stabilitätsprüfungen (ICHQ1)
- Sehr gutes analytisches Denken, Organisationsvermögen und lösungsorientiertes Arbeiten
- Erfahrung mit der Interpretation und Bewertung wissenschaftlicher Daten
- Versierter Umgang mit den gängigen MS-Office-Applikationen
- Hohes Maß an Verantwortungsbewusstsein und intrinsischer Motivation
- Ausgeprägte Teamfähigkeit und sehr gutes Kommunikationsvermögen
- Sehr gute Deutsch- und Englischkenntnisse
Wir bieten
- New Work, flexible Arbeitszeiten und Mobiles Arbeiten
- Vielfältige Benefits wie z.B. Hansefit, Jobrad, Deutschlandticket, Kindergartenzuschuss und Kauf zusätzlicher Urlaubstage
- Umfassendes Onboarding- und Mentoring-Programm
- Individuelle Weiterbildungsmöglichkeiten
- Internationales und wachsendes Familienunternehmen mit kurzen Entscheidungswegen und finanzieller Unabhängigkeit
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