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Qualified Person

vor 5 Monaten

Wien, Wien, Österreich Talentor Austria Vollzeit
Werden Sie Teil eines führenden pharmazeutischen Unternehmens

Unser Klient ist ein Top-Player am österreichischen Pharmamarkt dessen Portfolio bestens etabliert ist.

Ab sofort wird eine engagierte und kommunikationsstarke Qualified Person gesucht:



Qualified Person (QP) / Sachkundige Person (w/m/x)

Voll- oder Teilzeit

IHRE KÜNFTIGE ROLLE
  • Überwachung und Prüfung von Chargen gemäß den gesetzlichen Vorschriften, EU GMP-Richtlinien (Annex 16), EU GDP-Richtlinien, der österreichischen "Arzneimittelbetriebsordnung" (AMBO)
  • Gewährleistung der ordnungsgemäßen Erstellung, Verifizierung und Genehmigung von Herstellungs-, und Verpackungsdokumentation
  • Ausarbeitung oder Beteiligung an der Erstellung / Überarbeitung von SOPs für Arzneimittel
  • Durchführung der Bewertung von arzneimittelrelevanten Non Conformities und Changes
  • Unterstützung bei der Definition und Erstellung von Vorgaben im Zuge der Zulassung von neuen Arzneimitteln (Projektumfeld)
  • Aktive Mitarbeit bei arzneimittelrechtlichen Inspektionen (z.B. von Gesundheitsbehörden)
  • Verantwortlich für die Qualifizierung von neuen, kritischen Lieferant*innen betreffend Arzneimittel sowie Planung und Durchführung von EU GMP Audits (Lieferant*innen, Lohnhersteller / -verpacker in und außerhalb der EU sowie Drittstaaten)
  • Mitwirkung bei der Erstellung von jährlichen Product Quality Reviews & Bewertung von Complaints
  • Enge Zusammenarbeit und aktive Kommunikation intern und extern


IHRE QUALIFIKATIONEN
  • Berechtigung zur Ausübung der Funktion einer Sachkundigen Person gemäß § 7 Abs. 3 AMBO 2009
  • Einschlägige Berufserfahrung in der pharmazeutischen Industrie / Herstellung - Erfahrung in der pharmazeutischen Qualitätssicherung von Vorteil
  • Solide Kenntnis der in der pharmazeutischen Herstellung anzuwendenden Richtlinien und Qualitätsstandards (GMP, GCP) und der daraus resultierenden Anforderungen
  • Erforderliche Kenntnisse zu positionsrelevanten Regularien (EU GMP & EU GDP)
  • Exzellente Projektmanagementskills & die Fähigkeit, Prioritäten zu setzen
  • Resilienter Teamplayer mit kritischem Denkvermögen und einer "Can-do"-Mentalität
  • Inspektionserfahrung ist von Vorteil
  • Sehr gute Deutsch- und Englischkenntnisse in Wort und Schrift sowie sehr gute MS Office-Kenntnisse und digitale Affinität


DAS BESONDERE AN DIESER POSITION
  • Renommiertes Unternehmen mit flachen Hierarchien und schnellen Entscheidungswegen
  • Abwechslungsreiche Tätigkeiten
  • Zahlreiche Gestaltungs- und We