Regulatory Compliance Assistant

vor 2 Wochen


Bern, Schweiz Oxford Global Resources Vollzeit

**Regulatory Compliance Assistant (m/w/d)**:

- Location:
Bern, Switzerland
- Contact:
Elisa Miranda
- Job type:
Temp to Perm
- Industry:
Pharmaceutical

Unser Kunde sucht einen qualifizierten Kandidaten zur Verstärkung seines Teams als Regulatory Compliance Assistant (m/w/d). In dieser Funktion sind Sie für die Unterstützung des Regulatory Compliance Teams bei verschiedenen Aufgaben verantwortlich.
**Stellenbeschreibung**
Als Regulatory Compliance Assistant (m/w/d) unterstützen Sie das Team bei Aufgaben wie der Durchführung von Behörden
- und Kundeninspektionen, der Vorbereitung von GMP-Dokumenten für die Einreichung von Zulassungsanträgen, der Beantwortung von Fragen der Aufsichtsbehörden, der Koordinierung von papierbasierten GMP-Inspektionen und der Vorbereitung von GMP-Zertifikatserneuerungen und ausschreibungsrelevanten Unterlagen. Darüber hinaus sind Sie für die rechtzeitige Umsetzung von Maßnahmen zur Einhaltung von Vorschriften verantwortlich und unterstützen bei der Beantwortung interner und externer Fragen zur Einhaltung von Vorschriften.
**Verantwortungen**
- Durchführung von Behörden
- und Kundeninspektionen am Standort
- Vorbereitung von GMP-Dokumenten für Zulassungsanträge
- Beantwortung von Fragen der Aufsichtsbehörden
- Koordinierung, Durchführung und Nachbereitung von GMP-Inspektionen auf Papier
- Vorbereitung der Erneuerung von GMP-Zertifikaten und der entsprechenden Ausschreibungsunterlagen
- Sicherstellung der rechtzeitigen Umsetzung von Maßnahmen zur Einhaltung von GMP Regularien
- Erledigung von Ad-hoc-Aufgaben in spezialisierten Bereichen

**Profil**
- Universitäts
- oder Fachhochschulabschluss in einem naturwissenschaftlichen Gebiet (z. B. Biologie, Chemie oder Pharmazie)
- Erfahrung im Bereich Qualität oder Herstellung in einer pharmazeutischen GMP-Umgebung
- Fließende Beherrschung der deutschen und englischen Sprache (in Wort und Schrift)
- Ausgeprägte Kommunikationsfähigkeiten
- Nachgewiesenes Interesse an technischen Prozessen

**Arbeitsbedingungen**
- Anstellung: Befristet bis zum 31.12.2023; Vertrag via Oxford Global Resources;
- Gehalt: Ca. 12.000€ pro Monat;
- Arbeitszeiten: Vollzeit, 41 Stunden pro Woche;
- Remote Arbeit: Möglich unter Absprache
- Standort: Bern (Schweiz).

Stellennummer: 22319
Telefonnummer: +49 211 88230196



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