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Qualification Engineer

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Neovii

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Standort:
Germany

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Kategorie:

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Vertragstyp:
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Gehalt:

Nicht angegeben

Verantwortlichkeiten:

  • Planung und Durchführung der Qualifizierung von Anlagen, Geräten, Ausrüstungsgegenständen und deren Software sowie von Räumen
  • Durchführung von Marktrecherchen und Einholung von Angeboten auf Basis der zuvor erstellten Lastenhefte
  • Erstellung selbständig Qualifizierungsdokumente mit den Aspekten der Planung, Durchführung, Berichtserstellung und Mangelnachverfolgung in Abstimmung mit den Fachbereichen und Lieferanten
  • Erstellung von Risikoanalysen, Ableitung ggf. erforderlicher Maßnahmen und Nachverfolgung deren Abarbeitung
  • Erstellung von SOPs und Arbeitsanweisungen
  • Leitung und Organisation von Qualifizierungsprojekten
  • Schulung der Mitarbeiter auf die Bedienung der Anlagen
  • Sicherstellung der Compliance mit gült

Anforderungen:

  • Naturwissenschaftliche Ausbildung oder Studium
  • Mind. 5 Jahre Erfahrung im pharmazeutischen Umfeld
  • Umfassende Berufserfahrung im Bereich Geräte-/Anlagenqualifizierung und GMP-konformer Dokumentation
  • Fundierte Fachkenntnisse aktueller GMP-Richtlinien für die Qualifizierung von Anlagen, Geräten, Ausrüstungsgegenständen und deren Systeme
  • Erste Erfahrungen im Projektmanagement sind wünschenswert
  • Erfahrung mit der Validierung computergestützter Anlagen nach EU GMP Annex 11, 21 CFR Part 11 und GAMP 5
  • Sorgfältige, gewissenhafte und teamorientierte Arbeitsweise
  • Eigeninitiative, Leistungsbereitschaft und hohe Zuverlässigkeit sowie Selbständigkeit
  • Dienstleistungsorientierung und Fokus auf Kundenzufriedenheit
  • Sprachkompetenzstufe (CEFR-System): Deutsch C1
  • Englisch B2

Wünschenswert:

Erste Erfahrungen im Projektmanagement sind wünschenswert

Was wir biete:
  • Flexible Arbeitszeiten (Gleitzeitmodelle, 37,5 Stunden/Woche, Home-Office-Tage)
  • attraktive Vergütung
  • 30 Urlaubstage
  • Wellpass-Mitgliedschaft

Zusätzliche Informationen:

Job veröffentlicht:
16. Februar 2026

Beschäftigungsart:
Vollzeit
Arbeitsart:
Hybride Arbeit
Job-Link teilen:

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