Sr Technician Gmp Operations
Vor 6 Tagen
Senior Technician GMP Operations (Fill and Finish)
Zu den Haupttätigkeiten gehören unter anderem:
- Praktische Durchführung der Fill&Finish Entwicklungs
- und Produktionsarbeit (Experimente, Produktionen und Tests) unter Leitung von Teamleader/Stellvertreter und gemäss geltenden Vorschriften (cGMP, SOP, MBR)
- Mitwirkung bei der Herstellung von sterilen Produkten gemäss Produktionsplan: hierbei überwiegend im Bereich Material
- und Equipmentvorbereitung, aseptische Abfüllung, visuelle Kontrolle von abgefüllten Einheiten, Musterzug etc.
- Dokumentation von Experimenten/Produktionen und Ergebnissen gemäss geltenden Vorschriften (GMP compliant)
- Mitwirkung bei der Batchnachbearbeitung, d.h. Reinigung von Equipment, Räume und Vollständigkeit der Batchdokumentation
- Diskussion von Ergebnissen, Beteiligung an Fehlersuche und Identifizieren von Verbesserungsmöglichkeiten-Verantwortlich für Das Redigieren oder Erstellen von Arbeitsvorschriften und Protokollen
- Organisation der Prozessräume (GMP-Bereich), einschliesslich Sicherheit und Sicherheitsverfahren-Unterstützung der Installation und Qualifikation von neuer Ausrüstung
- Verwalten, Bewirtschaften und Instandhaltung von zugeteilten Reinräumen, Einrichtungen und Ausrüstung-Durchführung von Raum
- und Batchmonitoring unter Koordination des Monitoring-Verantwortlichen-Unterstützung bei Validierungen, Änderungsanträgen und der Wartung von Einrichtungen
**Qualifications**:
Wen wir suchen:
- Abgeschlossene Berufsausbildung im Bereich Pharma/Biotechnologie, Lebensmittel oder verwandter Disziplin
- Erfahrung im hygienischen und/oder sterilen Arbeiten und GMP Umfeld-Erfahrung im Bereich aseptischer Herstellung/Visueller Inspektion von Vorteil
- Teamfähig sowie selbstständige und gewissenhafte Arbeitsweise-Bewusstsein für die anhaltende Verbesserung der Prozesse
- Die Fähigkeit nach engen und herausfordernden Zeitvorgaben zu arbeiten
- Fliessende Deutsche Kommunikation in Wort & Schrift, Englisch von Vorteil-Bereitschaft zum 2-Schicht-Betrieb (aktuell Tagesbetrieb)
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