Validation Expert

vor 1 Monat


Basel, Schweiz Flexsis Vollzeit

**INTRODUCTION**:
Als Preferred Supplier für Roche Basel in Kaiseraugst suchen wir eine engagierte Persönlichkeit als

**Validation Expert**:

- (Vertrag bis 31.12.2025 mit Möglichkeit auf Verlängerung bei gegenseitigem Einverständnis) mit Startdatum so rasch wie möglich.

**ASSIGNMENT DESCRIPTION**:

- Zusammenarbeit mit internen und externen Schnittstellen (v.A. Labore und Value Streams), praktische Durchführung und Dokumentation aller Reinigungsvalidierungsmusterzüge in den Betrieben
- Probenzug, Probenaufbereitung, Zusammenstellung, Auswertung und Dokumentation der Ergebnisse der durchgeführten Reinigungsvalidierungsmusterzüge
- Pläne, Berichte, Musterzugsprotokolle und SOPs erstellen/pflegen.
- Sicherstellung der termingerechten Reinigungsvalidierungs-Aktivitäten unter Einhaltung aller GMP Vorgaben und Prozesse
- Sicherstellung der Erfüllung der Kundenanforderungen in der Produktion in Bezug zur RV
- Risikobewertungen zum Thema Reinigung
- ADC Monitoring, Spill und Small Scale Studies, Cleaning Assessments
- Launches /Tech Transfers im Bereich Reinigungsvalidierungen
- Troubleshooting bei reinigungsbezogenen Produktionsprozessen, Durchführung von Ursachenanalysen, Erstellung von Product Quality Impact Beurteilungen
- DOC SPOC, SME für PQS Dokumente
- Unterstützen bei Verbesserungsvorschlägen und Prozessoptimierungen
- Einhaltung der SGU Richtlinien
- Unterstützung des Teamgedankens und der Teamarbeit zum selbständigen Arbeiten
- Sicherstellen eines ausreichenden Informationsflusses innerhalb des Teams und mit Schnittstellen

**REQUIRED PROFILE**:

- Abgeschlossenes Hochschulstudium oder vergleichbare Ausbildung
- Min. 2 Jahre praktische Berufserfahrung im Bereich Reinigungsvalidierung innerhalb einer pharmazeutischen Produktion, insbesondere im Umgang mit Proben
- Min. 2 Jahre Berufserfahrung in einem GMP regulierten Arbeitsumfeld
- Erfahrung in der Schnittstellenkommunikation
- Interesse an der Analytik
- Bereitschaft sich konstant Weiterzuentwickeln und neue Aufgaben zu übernehmen
- Eine hohe Teamfähigkeit
- Agile und kreative Denkweise
- Flexibilität, Agilität und den Willen eine Lean Kultur umzusetzen
- Gute Englisch & fliessende Deutschkenntnisse

**Nice to haves**:

- EVAL Roche

**Bewerbungsprozess**:
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