Documentation and Compliance Manager
vor 2 Wochen
**EINFÜHRUNG**:
Unser Beruf und unsere Leidenschaft «HR-Management».
Global Personal ist ein eigenständiges Unternehmen der Interiman Group SA mit über 100 Mitarbeitenden, die an 21 Standorten in der Deutschschweiz ein komplettes Programm von Dienstleistungen im Bereich Human Resources anbieten.
Für unseren Mandanten, ein Pharma-Unternehmen Basel suchen wir ab sofort oder nach Vereinbarung eine zuverlässige Persönlichkeit m/w/d als
**Documentation and Compliance Manager 100%**:
**AUFGABENBESCHREIBUNG**:
- Unterstützt die Untersuchung von Geschäftsbeschwerden, wertet die jährliche Beschwerdeanalyse aus und unterstützt Folgeaktivitäten, z. B. Ursachenforschung, anschließende Korrektur
- und Vorbeugungsmaßnahmen (CAPA) und Änderungen (technisches Änderungsmanagement, Verlagerungen, Kapazitätserweiterungen).
- Unterstützt und leitet technische Änderungen, z. B. Designänderungen, Einführung neuer therapeutischer Indikationen, Aufnahme zusätzlicher Lieferanten, vom Lieferanten initiierte Änderungen
- Verwaltung des Product Care Annual Review (PCAR)
- Sicherstellung der Einhaltung von Vorschriften und internen GMP-Standards (z.B. abteilungsinternes Archivierungskonzept, Records Management und Schulungen)
- Umsetzung der Anforderungen des Pharma-Qualitätssystems in lokale betriebliche Prozesse
- Unterstützung von internen/externen Qualitäts-/Regulierungs-/SGU-Inspektionen
- (Re-) Präsentation von PTDE-D in Projektteams, Qualitätsausschüssen und Leitungsgremien, je nach Bedarf als Fachexperte (SME)
- Leitung des Onboardings neuer Mitarbeiter und Verwaltung des Schulungssystems
**ERFORDERLICHES PROFIL**:
- Bachelor-/Master-Abschluss (Pharmazie, Pharmazeutik, Bioingenieurwesen, Chemie oder ein anderer relevanter Bereich) und erste Erfahrungen in der pharmazeutischen oder einer verwandten Branche
- Nachgewiesene Erfahrung im Projektmanagement
- Fundierte Kenntnisse der Rechtsvorschriften, Regelungen, Industrienormen und Leitlinien im Bereich der Kombinationsprodukte und Medizinprodukte
- Erfahrung im Umgang mit Gesundheitsbehörden
- Ausgezeichnete Kommunikations
- und Verhandlungsfähigkeiten in Deutsch und Englisch mit Erfolg beim Aufbau vertrauensvoller Beziehungen
- Selbstmotiviert, proaktiv, verantwortungsbewusst, ergebnisorientiert und ein ausgezeichneter Teamplayer
- Erfahrung in der Arbeit in einem agilen Umfeld und im Einsatz von Lean-Tools
Nice to haves:
- Nachgewiesene Erfahrung im Bereich Compliance Management und Dokumentation in der pharmazeutischen oder einer verwandten Industrie
Start: ASAP - spätestens 18.09.2023
Wir bieten dir eine spannende Herausforderung in einem internationalen Unternehmen mit einem motivierten und engagierten Team. Wenn Sie Teil dieses Teams werden möchten, freuen wir uns auf Ihre Bewerbung
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