QA Manager Production

vor 2 Wochen

St Gallen, Schweiz CSL Behring Vollzeit

Für unseren modernen Produktionsstandort in St. Gallen und zur Verstärkung unseres Qualitätsteams suchen wir eine(n) motivierte(n)

**QA Manager Produktion**:
Zu den Hauptverantwortlichkeiten gehören die Mitarbeit im Supply Team der QA Produktion Gruppe und die Sicherstellung der Lieferperformance von API am Standort St. Gallen. In dieser Position berichten Sie direkt an den Gruppenleiter QA Produktion.

**Verantwortlichkeiten**:

- Ansprechperson in der QA Produktion Gruppe
- Mitarbeit im Supply Team API und Bearbeitung von Abweichungen, Batch Rekord Review bei der VIT hergestellten Produkte
- und SAP-Freigaben
- Laborbetreuung (Methoden Validierung, Abweichungen)
- Sicherstellung der GMP-Compliance in den Verantwortungsbereichen
- Durchführung von internen Audits
- Bearbeitung von Änderungsanträgen
- Erstellung und Review von Vorschriften und Arbeitsanweisungen
- GMP-Support für andere Abteilungen
- Mitwirken in Entwicklungs
- und Optimierungsprojekten zur Sicherstellung der Einhaltung der GMP-Anforderungen als QA-Beauftragter
- Betreuung der Qualifizierung technischer Systeme gemäss GMP-Anforderung (Review und Unterzeichnung der zugehörigen Dokumentationen) inkl. deren Inbetriebnahme
- Planung und Durchführung von Reinigungs
- und Prozessvalidierungen in der Produktion VIT (inkl. Erstellung der entsprechenden Berichte und Pläne)
- Betreuung von Um
- Neubauten am Standort

**Kompetenzen**
- Informationsrecht intern und extern bezüglich der zu erledigenden Aufgaben
- Freigabe der Produktionsanlagen und Zwischenstufen
- Genehmigung von GMP Dokumenten

**Qualifikationen**:

- Ausbildung an einer Fachhochschule oder einer Universität mit Abschluss in Chemie, Pharmazie, Biologie oder ähnlichem
- Fähigkeiten die Aufgaben ordnungsgemäß selbständig durchzuführen
- Fähigkeit Projekte bezüglich Produktionsanlagen und Herstellprozesse als QA Verantwortlicher zu betreuen
- Erfahrung in den Bereichen Monitoring in der Pharma-Produktion, Mikrobiologie, Qualifizierung und Validierung und Change Control
- Teamfähigkeit
- Belastbarkeit
- Deutsch fließend, Englisch in Wort und Schrift

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.**

**About CSL Vifor**:
CSL Vifor aims to become the global leader in iron deficiency and nephrology.

The company is a partner of choice for pharmaceuticals and innovative patient-focused solutions across iron, dialysis, nephrology and rare conditions. CSL Vifor strives to help patients around the world with severe, chronic and rare diseases lead better, healthier lives. It specializes in strategic global partnering, in-licensing and developing, manufacturing and marketing pharmaceutical products for precision patient care.

**We want CSL to reflect the world around us**:
As a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.

**Do work that matters at CSL Vifor**:

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