Qualification Expert
vor 1 Woche
Für einen renommierten Kunden Region Basel suchen wir eine/-n:
Qualification Expert 100%
Tätigkeiten:
* VerantwortlichfürdiePlanungundDurchführungvonQualifizierungs- undValidierungsaktivitäten* ErstellungundÜberprüfungvonQualifizierungs- undValidierungsdokumenten(DQ, IQ, OQ, PQ)* DurchführungundDokumentationvonQualifizierungsprozessenfürunsereEmbeddedSystems/ ProzessautomationssystemenachcGMP* Entwicklung, ImplementierungundDurchführungvonTeststrategien, TestplänenundTestfällenzurÜberprüfungderSystemleistungundCompliance* BereitstellungvonFachwissenbeiderErstellungvonSpezifikationen(z.B. URS).* ZusammenarbeitmitdenAbteilungenIT, Verfahrenstechnik/ Automatisierung, QualitätssicherungundProduktion, umeinereibungsloseIntegrationundQualifizierungderSystemezugewährleisten.* UnterstützungbeiderBearbeitungvonAbweichungen, ÄnderungenundCAPAsQualifikationenVoraussetzungen:
* Technischer Abschluss in einem relevanten Bereich* Weiterbildung und Praxiserfahrung im Bereich GMP * Mindestens 3-5 Jahre Erfahrung in der Qualifizierung und Validierung von Maschinen und Prozessen, vorzugsweise in der pharmazeutischen Industrie* Mehrjährige Berufserfahrung in der Qualifikation* Erfahrung mit Siemens COMOS, EVAL (ValGenesis) und VIVA *** DeutschkenntnisseinWortundSchrifterforderlich, EnglischkenntnisseinWortundLesen
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Elian Saladin-
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