29408-1 Sr. CTS Packaging

vor 4 Wochen

Marburg, Deutschland Pharmiweb Vollzeit

Für einen namenhaften internationalen Kunden aus der Pharmabranche, suchen wir aktuell Unterstützung als Clinical Studies - CTS Packaging & Labeling Specialist (m,w,d) in Mittelhessen für zunächst 1 Jahr im Rahmen einer Arbeitnehmerüberlassung.

Für diese Position bringen Sie idealerweise erste Erfahrungen mit klinischen Studien mit.

Stellenbeschreibung:

  • Etikettenübersetzung und -generierung über das externe Dienstleistersystem
  • Entwicklung von Verpackungsplänen (sicherstellen, dass alle Dokumentationen und Zeitpläne beim externen Verpackungsanbieter für Verpackungsläufe vorhanden sind)
  • Verwaltung von Etiketten und Verpackungen bei externen Dienstleistern
  • Leitung von Besprechungen mit externen Dienstleistern und CTS-Studienleitern, um sicherzustellen, dass die Zeitvorgaben eingehalten werden
  • Planung und Koordination der Kennzeichnung, Verpackung und Freigabe von Prüfpräparaten (IMP) für alle globalen klinischen Programme
  • Bereitstellung von Etikettentexten für IMP in Übereinstimmung mit länderspezifischen Vorschriften
  • Bereitstellung von IMP für Investigator Initiated Trials (IITs)
  • Quality: Entwicklung, Überprüfung und Überarbeitung von SOPs, Formularen und Vorlagen in Bezug auf Verpackung und Kennzeichnung

Qualifikationen:

  • Idealerweise Erfahrungen mit klinischen Studien
  • Verständniss für das GMP Konzept, Idealerweise Berufserfahrung unter GMP
  • Fließende Deutsch- und Englischkenntnisse

Nice-to-have:

  • Erfahrung in Verpackung und Etikettierung im Arzneimittelbereich


Sollten Sie Fragen oder Schwierigkeiten bei der Bewerbung haben, wenden Sie sich bitte an Maik Thieme unter der m.thieme@proclinical.com.

Proclinical ist eine spezialisierte Personalberatung, die berufliche Chancen in der pharmazeutischen, biopharmazeutischen, biotechnologischen und medizintechnischen Branche anbietet.

Proclinical Staffing ist außerdem ein Arbeitgeber der Chancengleichheit.

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