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Data Integrity Specialist

vor 2 Monaten

Bielefeld, Nordrhein-Westfalen, Deutschland Planet Pharma Vollzeit
Jobbeschreibung

Wir suchen einen erfahrenen Data Integrity Specialist für unser Team bei Planet Pharma.

Als Quality Assurance Specialist sind Sie für die Sicherstellung der Compliance bei Herstellungsprozessen und -anlagen zuständig. Sie agieren als Schnittstelle zwischen Produktion und Qualitätssicherung zur:

  • Umsetzung von Data Integrity Vorgaben des Unternehmens, um zu gewährleisten, dass die Daten bei der Erfassung, Bearbeitung, Speicherung und Übertragung sicher, korrekt und konsistent sind.
  • Erarbeitung von Lösungen zur Verbesserung der Datenqualität
  • Evaluierung von Fehlern oder Inkonsistenzen, die während des Erfassungs-, Speicher- oder Übertragungsprozesses aufgetreten sein könnten
  • Empfehlung, Nachverfolgung und Dokumentation von Problemlösungen
  • Überwachung der Einhaltung von Vorschriften in Bezug auf die Erhebung und Speicherung von Daten
  • Festlegung und Durchsetzung von Sicherheitsrichtlinien zum Schutz sensibler Daten vor Verlust oder unbefugtem Zugriff
  • Untersuchung von Datenintegritätsverletzungen
  • Erstellung von SOPs und anderen Dokumenten (Testpläne und Berichte)

Wir erwarten von Ihnen:

  • Ein abgeschlossenes Bachelorstudium aus dem Bereich Computer Science, Informatik, IT, Datenbankverwaltung oder ähnliches
  • Idealerweise Erfahrung im pharmazeutischen/medizintechnischen Umfeld
  • Kenntnisse der Anforderungen an Electronic Records und Signatures (Data Integrity) wie 21 CFR-Part 11, EU GMP Annex 11
  • Idealerweise Good Documentation Practice-Kenntnisse
  • Gute Kommunikationsfähigkeit sowie eine selbstständige Arbeitsweise
  • Sehr gute Deutsch- und Englischkenntnisse in Wort und Schrift

Über Planet Pharma

Planet Pharma ist ein führender Anbieter von Lösungen für die pharmazeutische Industrie. Wir arbeiten eng mit unseren Kunden zusammen, um ihre Herausforderungen zu lösen und ihre Ziele zu erreichen.