QA Manager Supplier Qualification

Vor 4 Tagen


Kirchberg SG, Schweiz TN Switzerland Vollzeit

Für den Standort Kirchberg SG, Schweiz

Sie möchten einen wertvollen Beitrag für die Gesundheit von Patient*innen leisten? Und eigenverantwortlich etwas wirklich Sinnvolles bewirken? Dann freuen wir uns auf Sie Excellence beyond manufacturing – dafür stehen wir als Aenova, einer der weltweit führenden Auftragshersteller und -entwickler für die Pharmaindustrie mit 4.000 Mitarbeitenden an 15 Standorten. Unser Standort in Kirchberg SG ist Kompetenzzentrum für die Entwicklung und Produktion von Softgel-Kapseln.

Aufgabengebiet

  1. Lieferantenqualifizierung, Lieferantenaudits und -bewertungen von Rohstoffen/Packmitteln, externen Lohnherstellern und Lohnlaboren sowie externen Dienstleistern gem. behördlichen Richtlinien (Swissmedic, FDA, BRC)
  2. Termingerechte Audit-Berichterstellung sowie deren Jahresplanung
  3. Nachverfolgung von CAPA-Massnahmen
  4. Pflege der Rohstoffdatenbank/Dokumentenanforderung und Abklärung von Kundenanfragen mit den Lieferanten
  5. Erstellung von "Excipient Risk Assessments" und Monitoring regulatorischer Updates

Ihr Profil

  1. Hochschulabschluss Chemie/ Lebensmittelchemie / Pharmazie oder Berufsfachleute aus dem pharmazeutischen Bereich mit entsprechender Weiterbildung
  2. Mindestens 3 Jahre Berufserfahrung im regulatorischen Qualitätsumfeld, vorzugsweise in der Qualitätssicherung sowie nachweisbare Kenntnisse im Arzneimittel- oder Lebensmittelbereich
  3. Mehrjährige Auditerfahrung erforderlich, firmenintern/firmenextern und idealerweise mit Aufsichtsbehörden (vorzugsweise FDA und Swissmedic)
  4. Verständnis für Dokumentationswesen (Datenbanksysteme)
  5. Sehr gute MS-Office Kenntnisse und SAP-Kenntnisse wünschenswert
  6. Sehr gute Deutsch-/Englischkenntnisse in Wort und Schrift

Ihre Motivation

Sie suchen neue Herausforderungen in einem wettbewerbsstarken Umfeld? Und die wollen Sie kreativ und eigenverantwortlich anpacken? Sie bevorzugen eine “get-it-done“-Kultur und denken lieber in Lösungen als in Problemen?

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