Quality Management Specialist
vor 5 Monaten
**Quality Management Specialist** (m/w/d)
**Anstellung bei der Hays Professional Solutions GmbH**
**München**
**Startdatum: sofort**
Referenznummer: 743112/1
**Bewerbung starten**
**Ihre Aufgaben**:
- Erstellung von Konformitäts-/KPI-Ausgaben und des ROD-Moduls zur systematischen Verfolgung und Archivierung/Ablage von CAPAs, um die rechtzeitige Umsetzung und den Abschluss über das Systemtool und/oder manuell sicherzustelle
- Unterstützung bei der CAPA-Entwicklung und/oder Implementierungsstrategie für ICSR-bezogene Qualitätsangelegenheiten
- Koordinierung geplanter CAPA-Aktivitäten mit den relevanten CAPA-Stakeholdern
- Überprüfung/Qualitätskontrolle von Nachweisen zur Sicherstellung der Übereinstimmung mit dem CAPA-Plan
- Unterstützung bei den administrative Tätigkeiten im Bereich des PV-Qualitätsmanagements, die für die optimale Funktion des Teams insgesamt erforderlich sind, wie z. B: Pharmakovigilanz System Master File
- Audits und Inspektionen
- Verfahrensdokumente und Schulungen
- Mitwirkung an globalen Projekten im Rahmen des globalen Qualitäts-, Compliance
- und PSMF-Teams zur Verbesserung des globalen PV-Qualitätsmanagementsystem
**Ihr Profil**:
- Bachelor-Abschluss in einem wissenschaftlichen und/oder qualitätsbezogenen Bereich, Master bevorzugt
- Erfahrung in der Bearbeitung von ICSRs/ Kenntnisse in der Fallbearbeitung
- Erfahrung im Umgang mit/bei der Bearbeitung von Pharmakovigilanz-CAPAs oder alternativ ein erfahrener Pharmakovigilanz-Auditor
- Fließende mündliche und schriftliche Kommunikationsfähigkeiten in Englisch
- Gute Kenntnisse der europäischen PV-Gesetzgebung
- Erfahrung im Umgang mit CAPAs oder Erfahrung mit GVP-Audits
- Effektive Zusammenarbeit mit verschiedenen Funktionen und Partnern in einem multidisziplinären und gemischten Umfeld
**Ihre Benefits**:
- Internationales Unternehmen
Über Hays
Ihr Bewerbungsprozess
Ihr Kontakt bei Hays
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