Cqv Lead
vor 2 Wochen
Für ein interessantes Projekt im Wallis, suchen wir einen CQV Lead ( **Commissioning, Qualification and Validation Engineer**).
Hauptverantwortung:
- Unterstützung des zugewiesenen Projekts als CQV-Manager für Production Support Equipment
- Leitung des zugewiesenen Teams für Arzneimittelhilfsmittel (DP) und Laborausrüstungen
- Überwachung der täglichen Validierungsaktivitäten in Übereinstimmung mit den genehmigten SOPs / Plänen / Richtlinien
- Teilnahme an der Überprüfung und Genehmigung von Validierungsprotokollen / Berichten, einschliesslich der Untersuchung von Abweichungen
- Unterstützung / Teilnahme an Validierungsaktivitäten während der Inbetriebnahme der Anlage
- Mindestens 6+ Jahre im Bereich Inbetriebnahme, Qualifizierung und Validierung inkl. CSV mit Erfahrung im Management von komplexen pharmazeutischen Projekten
- Erfahrung mit Biologika (Säugetiere, CGT), sowie chemischen Herstellungstechnologien wünschenswert
- Erfahrung in der Qualifizierung von produktionsunterstützenden Anlagen wie, Teilewaschanlagen, CIP/SIP- und Temperaturkontrollanlagen
- Erfahrung in der regulierten pharmazeutischen Industrie und/oder in einem Ingenieurbüro mit nachgewiesener Erfahrung in der Planung von CQV-Aktivitäten
- Ausgeprägte Kenntnisse der ISPE- und ASTM-Richtlinien mit nachweislicher Erfahrung in grossen und komplexen Projekten
- Nachgewiesene Managementerfahrung in einem EMA / FDA regulierten Umwelt mit sehr guten Kenntnissen der aktuellen ICH-, PIC/S-, EU- und US-Vorschriften Anforderungen und deren Umsetzung
- Erfahrung im Personalmanagement (intern und extern) in Bezug auf organisatorische Aspekte, Coaching und Entwicklung
- Hervorragende Kommunikations
- und Interaktionsfähigkeiten
- Deutsch und Englisch kommunikationssicher in Wort und Schrift
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