Quality Manager

Vor 4 Tagen


Pfaffenhofen an der Ilm, Bayern, Deutschland Daiichi Sankyo Europe GmbH Vollzeit
Wir suchen einen erfahrenen Qualitätsmanager (m/w/d) für die Qualitätskontrolle und Qualitätsmanagement.

Die Hauptaufgaben umfassen:

  • Implementierung neuer Qualitätsprozesse im GMP-Umfeld der Qualitätskontrolle (QC)
  • GMP-konforme Bearbeitung und Lenkung von pharmazeutisch-technischen Reklamationen (PTRs) im elektronischen Qualitätsmanagementsystem (eQMS)
  • Implementierung und Weiterentwicklung des Complaint Moduls im elektronischen Qualitätsmanagementsystem (eQMS)
  • Trending/Tracking von PTRs (KPIs)
  • Unterstützung bei Bearbeitung von Abweichungen/Störungen
  • Fachliche Führung bei Erstellung von Product Quality Reviews (PQRs)
  • Weiterentwicklung des Schulungssystems innerhalb der QC
  • Unterstützung bei verschiedenen QM-Tätigkeiten (zum Bsp. Change Tracking, Batch Records, Lieferantenreklamationen, Zertifikatserstellung)
  • Erstellung und Pflege von QM-bezogenen SOPs
  • Mitwirkung bei Selbstinspektionen, Kundenaudits und Behördeninspektionen

Wir bieten:

  • Attraktive Benefits
  • Work-Life-Balance
  • Persönliches Wachstum und Entwicklung
  • Gesundheit und Wohlbefinden


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