Subject Matter Expert Quality Management
vor 2 Wochen
**Stellenbeschreibung**:
CSL Behring ist ein weltweit führendes Biotech-Unternehmen, das sich seinem Versprechen verpflichtet hat, Leben zu retten. In Bern entwickeln und vertreiben wir mit über 1800 Mitarbeitenden lebensrettende Therapien für Menschen mit schweren und seltenen Krankheiten weltweit.
Für den Bereich Operational Services innerhalb des Departements Maintenance and Utilities am Standort Bern, suchen wir eine/n
**Subject Matter Expert Quality Management, Maintenance and Utilities (m/w/d)**:
In dieser Funktion sind Sie Mitglied in unserer Abteilung «Operational Services Maintenance and Utilities», in der wir als Team für die Unterstützung sämtlicher Qualitätsmanagement
- Anfragen und Herausforderungen des Businessbereichs «Maintenance and Utilities» zuständig sind.
**Ihr Aufgabengebiet umfasst**:
- Support und Betreuung von Änderungsanträgen des Bereichs Maintenance and Utilities im Rahmen der Optimierungs-Projekte und Obsolescence Management
- Bearbeitung von Abweichungen (wie z.B. technisch bedingte Prozessabweichungen)
- Ansprechpartner für Medien-Monitoring und Änderungsanträge/Abweichungen im Bereich «Maintenance and Utilities» bei Inspektionen sowie für alle Qualitätssicherheitsanfragen (z.B. Schulungen zu SOP’s) innerhalb des Bereichs
- Bearbeitung von Risikoanalysen und Vorbeugemassnahmen sowie Bereitstellen von Schulungen und Informationen zu auftretenden Risiken
- Troubleshooting bei möglicher Gefährdung
- Intensive und vertrauensvolle Zusammenarbeit mit allen Stakeholdern des Maintenance and Utilities -Businessbereichs sowie weiteren Stakeholdern
- Sicherstellung der Einhaltung von Compliance-Vorgaben sowie stetige Weiterentwicklung des Systems
**Qualifikationen & Berufserfahrung**:
- Erfolgreich abgeschlossenes Studium oder Berufsausbildung im Bereich Technik, Engineering oder Labor
- Berufserfahrung im Qualitätsmanagement und in einem GMP-regulierten Umfeld bevorzugt
- Erfahrung in der Qualifizierung der Anlagen, sowie im Erstellen und Prüfen von Berichten und SOPs
- Eigeninitiative Persönlichkeit, die die Aufträge selbständig vorwärtstreibt
- Neugieriger und lösungsorientierter Teamplayer mit offener und positiver Persönlichkeit
- Sehr gute und partnerschaftliche Kommunikations
- und Koordinationsfähigkeiten
- Effiziente und strukturierte Arbeitsweise auch in zeitlich herausfordernden Situationen
- Verhandlungssichere Deutschkenntnisse sowie gute Englischkenntnisse (in Wort und Schrift) runden Ihr Profil ab
Fühlen Sie sich angesprochen? Dann freuen wir uns auf Ihre Online-Bewerbung. Ihre Bewerbung sollte ein Motivationsschreiben, einen Lebenslauf/CV sowie Arbeitszeugnisse und Kopien von Diplomen in der Originalsprache und/oder relevante Transkripte beinhalten. **Bitte fügen Sie Ihre Dateien, inklusive CV, zu einem Dokument zusammen.**
- CSL Behring verpflichtet sich dem Prinzip der Chancengleichheit. _
**About Us**:
**Our Benefits**
We encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL.
About CSL Behring
CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.
We want CSL to reflect the world around us
As a global organisation with employees in 35+ countries, CSL embraces diversity, equity and inclusion. Learn more about Diversity, Equity & Inclusion at CSL.
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