Quality Manager Laboratory Systems
vor 7 Monaten
**Your tasks**:
- Sicherstellung, Überwachung und kontinuierliche Verbesserung des Qualitätsmanagementsystems bei R&D Graz auf Basis nationaler und internationaler Qualitätsstandards
- Unterstützung der Abteilungen Formulierungsentwicklung & analytische Entwicklung hinsichtlich diverser Qualitätsbelange (EU-GMP, cGMP und ISO 9001)
- Erstellung und Überarbeitung von lokalen SOPs sowie Bewertung und Implementierung qualitätsrelevanter Konzernvorgaben
- Erstellung, Bewertung, Monitoring und Abschluss von Abweichungs-, Change Control-, Reklamations
- und CAPA-Prozessen
- Durchführung von internen Audits und Monitoring der daraus entstandenen Maßnahmen
- Unterstützung bei Audits durch Behörden bzw. Vertragspartner (Backoffice)
- Administration, Sicherstellung und Überwachung des Qualitätssicherungssystems in puncto OOX-Ergebnisse
- Prüfung, Freigabe und Administration von Analytischen Worksheets
- Prüfung und Freigabe von Stabilitätsdokumenten im Zuge von Produktentwicklungen
- Prüfung und Freigabe von Methodenvalidierungs
- und Verifizierungsdokumenten
- Prüfung und Freigabe von Spezifikationen
- Moderation und Dokumentation von Risikobeurteilungen
- Unterstützung bei Qualifizierung und Validierung von Geräten und Systemen
**Our expectations**:
- Abgeschlossene Ausbildung im naturwissenschaftlichen Bereich (z.B. Pharmazie, Chemie, Biologie) oder einschlägige Berufserfahrung im Bereich der Qualitätssicherung
- Erfahrung im pharmazeutischen Qualitätssicherungswesen (EU-GMP, cGMP) oder im Qualitätsmanagement (ISO 9001)
- Umfassende MS-Office Kenntnisse
- Sehr gute Deutsch
- und Englischkenntnisse
- Exzellente Kommunikationsfähigkeit, Konfliktfähigkeit und starke Teamorientierung
- Eigeninitiative, Flexibilität und Durchsetzungsvermögen
- Proaktive, selbstständige und genaue Arbeitsweise
- Erfahrung im Erstellen von Risikoanalysen von Vorteil
- Projektmanagementerfahrung von Vorteil
- Interesse und Verständnis für IT Themen und/oder Datenbanken
**We offer**:
- Ein sehr interessantes und abwechslungsreiches Aufgabengebiet in einem international agierenden Unternehmen
- Fortbildungsmöglichkeiten und persönliche Weiterentwicklung innerhalb des Unternehmens
- Karrieremöglichkeiten in einem internationalen Pharmakonzern
- Vollzeit
- oder Teilzeitstelle im Ausmaß von mind 25 Wochenstunden
- Attraktive, leistungsorientierte Vergütung (Jahresbruttobezug mind. Eur 43.500,-; auf Basis Vollzeit, Überzahlung je nach Qualifikation)
**We are caring for our employees**:
- Reliable employer
- Strong global growth
- International career opportunities
- Comprehensive education and training
- Homeoffice
- Jobticket
- Active health promotion
- Free parking space
- Bikeleasing
- Canteen
- Joint company events
Fresenius Kabi Austria
Frau Mag. Sieglinde Walcher
Hafnerstraße 36
8055 Graz
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