Technical Compliance Manager

Vor 2 Tagen


Basel, Schweiz We make it GmbH Vollzeit

Die We make it GmbH ist ein national tätiges Unternehmen in der Schweiz, das dank langjähriger, erfolgreicher Erfahrung über eine hohe Kompetenz im Bereich der Personaldienstleistungen verfügt.

Konzentration der Vermittlungsaktivitäten auf die Kernbereiche Industrie, Technik, Büro/Verwaltung, Engineering, Pharma und IT. Die We make it GmbH stellt höchste Ansprüche an Qualität, Ethik und Diskretion.

Für unseren Kunden, ein internationales Pharamunternehmen mit Sitz in Basel suchen wir einen Technical Compliance Manager (m/w/d).

Aufgaben

**Beschreibung**:
Das Department Technische Compliance ist auf der Suche nach Technical Compliance Manager für die Betreuung, Koordination & Implementierung von Qualitätsprozessen innerhalb des Engineerings & Technischen Services in Basel & Kaiseraugst.

**Ihre Aufgaben**:

- Koordination / Implementierung und Mitarbeit bei den Qualitätsprozessen (Änderungs-, Abweichungs-, Risk-, AuditManagement) der Technischen Services in Basel & Kaiseraugst
- Unterstützung und Mitarbeit bei der Bearbeitung von Änderungen, Abweichungen und allgemeinenVerbesserungsAktivitäten
- Prüfen neuester Entwicklungen bezüglich cGMP, kontinuierlichen Verbesserung der Prozesse sowie der verwendeten Systeme
- Unterstützung interner Kunden als anerkannter Berater in sämtlichen technischen GMP Fragestellungen
- Erstellung, Review und Update von Dokumenten z.B. Arbeitsanweisungen: Prüfung von Dokumenten zur Sicherstellung der GMP-Compliance und der guten Dokumentationspraxis sowie Koordination / Mitarbeit bei der Überprüfung und allenfalls Überarbeitung und Neustrukturierung von bestehenden Arbeitsprozessen (Prozessverbesserung)

Qualifikation

**Ihre Qualifikationen**:

- Abgeschlossenes technisches Studium oder abgeschlossene Berufsausbildung mit entsprechender Weiterbildung und mehrjähriger Berufserfahrung im genannten Bereich
- Mind. 3 Jahre praktische Erfahrung im Bereich Compliance/Qualitätssicherung von pharmazeutischen, chemischen, biotechnologischen oder Infrastruktur-Anlagen
- Praktische Erfahrung in der Umsetzung von technischen GMP-Anforderungen der Zulassungsbehörden (RHI, FDA,

EMA etc.) in Investitionsprojekten bzw. in der galenischen / chemischen Produktion oder Energie-/ Medienversorgung
- Gute EDV-Kenntnisse (MS Office, gSuite) - insbesondere der Umgang mit Excel & gsheet zur Datenverarbeitung
- Sehr gute Deutsch
- und gute Englisch
- Kenntnisse in Wort und Schrift werden vorausgesetzt
- Erfahrung in den Bereichen Werkstätten, Energiebetriebe, Haustechnik von Vorteil
- Kenntnisse bezüglich GMP Anforderungen an Instandhaltungs
- und Energieversorgungs-Prozesse von Vorteil

**Persönliche Anforderungen**:

- Teamplayer mit exzellenten Kommunikationseigenschaften und Verhandlungsfähigkeiten, sowie mit der Fähigkeit effektive und vertrauensvolle Beziehungen mit Kollegen und Mitarbeitern auf verschiedenen Ebenen aufzubauen
- Freundliches und sicheres Auftreten
- Strukturierter Arbeitsstil, logisches und analytisches Denkvermögen
- Eigenverantwortliche und selbständige Bearbeitung komplexer Aufgaben sowie zuverlässige Durchsetzung vereinbarter Prioritäten
- Verständnis & gute Orientierungsfähigkeit innerhalb einer Matrix-Organisation

Sind Sie interessiert?

Dann freut sich Frau Emina Becic auf Ihre Bewerbung zur vertraulichen Prüfung.



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