Qualification Coordinator Engineering
vor 1 Woche
- und Pharmaindustrie weltweit.
**Bachem. Leading Partner in Tides**
Um unser organisches Wachstum weiterführen zu können, sind wir kontinuierlich auf der Suche nach Fachkräften.
Um unser organisches Wachstum weiterführen zu können, sind wir kontinuierlich auf der Suche nach Fachkräften. Für die Abwicklung von Investitionsprojekten am Standort Bubendorf suchen wir für unser Team im Bereich Engineering eine Verstärkung in der Funktion als Qualification Coordinator Engineering.
**Ihre Aufgaben**
- Koordination/ Überwachung der Inbetriebnahme-Prüfung, Kalibrierung, Qualifizierung und Validierung von Anlagen und computerisierten Systemen
- Erstellung von Qualifizierungs-Dokumenten (URS, DQ Bericht, CSV-Dokumente, Qualifizierungspläne) und GEP-Testplänen für Anlagen und computerisierte Systeme auf Basis der Design Spezifikationen
- Verwaltung der Qualifizierungs
- und GEP-Testdokumentation
- Review der Design
- und Testdokumentationen von Lieferanten/ Herstellern
- Unterstützung bei der Prüfung / Pflege / Beschaffung der Lifecycle-Dokumentation von Systemen bis zum Projektabschluss
- Bearbeiten von Änderungskontrollanträgen für Anlagen und computerisierte Systeme
- Projektmitarbeit im Rahmen von Investitionsprojekten
- Mitarbeit bei der Erhaltung und laufende Verbesserung der cGxP-Compliance und der damit verbundenen Prozesse von Anlagen und computerisierten Systemen
- Mitwirkung bei der Vorbereitung, Betreuung und Nachbereitung von Behördeninspektionen
**Ihr Profil**
- abgeschlossenes Studium (mind. Bachelor) oder höhere Fachschule in Verfahrenstechnik, Maschinenbau, Chemie
- Kenntnisse im Planungsablauf von verfahrenstechnischen Anlagen und Verständnis der Design Spezifikationen / Funktionsweise von Anlagen
- einige Jahre Berufserfahrung im regulierten Umfeld (vorzugsweise GxP)
- sehr gute mündliche und schriftliche Ausdrucksweise in Deutsch und gute Englischkenntnisse
- Ausgeprägter Dienstleistungsgedanke sowie hohe Flexibilität und Belastbarkeit
***
**Unser Angebot**
Wir bieten Ihnen eine spannende und herausfordernde Tätigkeit in einem dynamischen und stark wachsenden Umfeld, welches Ihnen Abwechslung und Mitsprache garantiert.
Haben wir Ihr Interesse geweckt? Dann freuen wir uns auf Ihre vollständigen Bewerbungsunterlagen über unser Bewerbungsportal.
Erfahren Sie mehr über uns Bachem und lassen Sie sich von den spannenden Eindrücken unseres analytischen Umfeldes an unserem Standort in Bubendorf inspirieren
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