Stability Scientist
vor 1 Woche
**Stability Scientist (m/w/d)**
**Ihre Aufgaben**:
- Als Stability Scienist sind Sie für die Konzeption, Planung und Durchführung von Stabilitätsprogrammen in Übereinstimmung mit den behördlichen Anforderungen, Produktlizenzbeschränkungen und Branchenstandards verantwortlich.
- Sie werden auch an lokalen und globalen Stability Projekten teilnehmen.
- Planung von Studien: Erstellung/Design von einfachen Stabilitätsstudienkonzepten in englischer Sprache für alle Produkte
- Selbstständige Organisation und Überwachung von einfachen Stabilitätsstudien gemäß cGMP, SOPs und regulatorischen Richtlinien
- Koordinierung der Vor
- und Nachgenehmigung einer Studie
- Kostenkalkulation für Stabilitätsprogramme
- Koordinierung von Stabilitätsstudienaktivitäten mit den beteiligten Abteilungen, z. B. Produktion, QC und F&E, Koordinierung von Prüfplänen mit Laboratorien (in QC und/oder F&E), falls erforderlich - auch mit externen Unternehmen, Aufbau und Pflege enger Kooperationsbeziehungen mit wichtigen Interessengruppen
- Selbstständige, zeitnahe Erstellung/Überprüfung von Stabilitätsberichten, einschließlich der Zusammenstellung von behördenrelevanten Stabilitätsdaten
- Unterstützung des Abweichungsmanagements innerhalb der Stabilitätsprogramme
- Zeitnahe Umsetzung der zugewiesenen Maßnahmen aus CAPAs und Dokumentation im entsprechenden Qualitätssystem
- Unterstützung bei der Ursachenermittlung von größeren/kritischen Problemen
- Bearbeitung und Bewertung von Änderungsanträgen, Erstellung und Überprüfung von Stabilitätsdokumenten, z.B. SOPs, Handbüchern, etc. Ausarbeitung von Vorschlägen zur Änderungskontrolle
- Vorbereitung, Unterstützung und Nachbereitung von internen und externen Audits und Behördeninspektionen
**Ihre Qualifikationen**:
- Abgeschlossenes wissenschaftliches Studium (z.B. Bachelor, Master, PhD) in Pharmazie, pharmazeutischer Technologie, Biologie, Chemie oder vergleichbare Ausbildung
- Wissenschaftlicher Abschluss oder 3,5 Jahre Erfahrung in der pharmazeutischen Industrie (GMP) und/oder mehr als 3 Jahre Erfahrung im Bereich Stabilität
- GMP-Erfahrung bevorzugt
- Erfahrung mit aktuellen Industriestandards, bewährten Verfahren und behördlichen Anforderungen an Stabilitätsstudien bevorzugt
- Gute Beherrschung der englischen und deutschen Sprache in Wort und Schrift
- Kenntnisse in datenbasierter Arbeit und statistischer Analyse
- Erfahrung mit LIMS bevorzugt
- Präzise Kommunikation und effiziente Arbeit im Team
- Strukturierte und systematische Arbeitsweise
- Gute Problemlösungs
- und Verhandlungsfähigkeiten
**Wir bieten Ihnen**:
- Eine spannende, abwechslungsreiche und eigenverantwortliche Tätigkeit in der Sie Ihr Potenzial ausschöpfen können
- Wir ermutigen Sie, Ihr Wohlbefinden zu einer Priorität zu machen. Es ist wichtig und Sie sind es auch.
- Eine faire Vergütung die Ihrer Ausbildung, Alter und Erfahrung entspricht
- Hervorragende Entwicklungsmöglichkeiten
- Einen Arbeitgeber dem die Work-Life Balance seiner Mitarbeiter wichtig ist
**Sie haben Interesse?**:
Die DEKRA Arbeit Gruppe gehört als Teil der DEKRA SE zu den am stärksten wachsenden Personaldienstleistern in Europa.
In der Schweiz und im Fürstentum Liechtenstein sind wir mit sechs erfolgreichen Niederlassungen im Bereich der vermittlungsorientierten Personaldienstleistungen vertreten. Helfen Sie mit, dieses Erfolgsmodell weiter auszubauen und bewerben Sie sich noch heute.
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