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Open nowPosted 23 days ago

Quality Assurance Specialist/Quality Operations (m/w/d)

EURES job mobility portal246,096 open roles

Where
Linz-Wels, Austria
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Your applicationOpen nowQuality Assurance Specialist/Quality Operations (m/w/d)EURES job mobility portal · Linz-Wels, Austria

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This job: posted 23 days ago

The posting

Fresenius Kabi Austria, with headquarters in Graz and a further production site in Linz, is a subsidiary of Fresenius Kabi AG, a world leading manufacturer of infusion therapy and clinical nutrition products. Fresenius Kabi Austria has 1600 employees and ranges among the top enterprises of the region. 1 Quality Assurance Specialist/Quality Operations (m/w/d) Ihr Aufgabengebiet

* Qualitätspartner für die Analytik: Sie beraten und unterstützen Mitarbeitende in der Qualitätskontrolle, Mikrobiologie und chemischen Laboren in allen qualitätsrelevanten Fragestellungen

* Qualitätssicherung im operativen Umfeld: Sie treffen qualitätsrelevante Entscheidungen direkt vor Ort, bearbeiten Abweichungen und unterstützen bei der Lösung komplexer Qualitätsprobleme

* Bearbeitung und Bewertung von Qualitätssystemprozessen wie Abweichungen, Änderungen (Change Controls), CAPAs, Reklamationen und Ereignissen

* Erstellung, Prüfung und Genehmigung von Qualitätsdokumenten wie SOPs, Spezifikationen, Risikoanalysen sowie Qualifizierungs- und Validierungsunterlagen

* Betreuung von Qualifizierungs- und Validierungsaktivitäten inklusive Dokumentationsprüfung und Sicherstellung der GMP-Konformität

* Unterstützung bei Audits und Inspektionen sowie fachliche Ansprechperson für qualitätsrelevante Fragen von internen und externen Auditor:innen

* Mitarbeit an Projekten und kontinuierlichen Verbesserungsmaßnahmen zur Weiterentwicklung von Qualitätsprozessen, Datenintegrität und Compliance

Wir erwarten

* Abgeschlossenes naturwissenschaftliches oder technisches Studium (z. B. Pharmazie, Chemie, Biotechnologie, Lebensmitteltechnologie oder vergleichbar) oder entsprechende Berufserfahrung

* Mind. 2 Jahre Erfahrung im Bereich Quality Assurance und Quality Control in einem GMP-regulierten Umfeld

* Kenntnisse in den Bereichen Abweichungsmanagement, CAPA, Change Control, Qualifizierung und Validierung von Vorteil

* Ausgeprägtes Qualitäts- und Verantwortungsbewusstsein sowie eine strukturierte Arbeitsweise

* Freude an bereichsübergreifender Zusammenarbeit und an der Beratung unterschiedlicher Stakeholder

* Kommunikationsstärke, Durchsetzungsvermögen und lösungsorientiertes Denken

* Deutschkenntnisse (mind.B2-Niveau) und gute Englischkenntnisse

Wir bieten

* Sehr abwechslungsreiches Aufgabengebiet

* Eine offene Firmenkultur mit vielseitigen Möglichkeiten im internationalen Kontext

* Entwicklungsperspektiven eines internationalen Pharmakonzerns

* Ein sehr engagiertes Team und ein sehr gutes Betriebsklima

* Attraktive, leistungsorientierte Vergütung (Jahresbruttogehalt mind. Eur 40.000,-; Bereitschaft zur Überzahlung je nach Qualifikation und Berufserfahrung)

HIER BEWERBENhttps://www.freseniuskabi-jobs.at/details-linz/stelle/8aa8ac8d9ecf5201019fffc0b7c36a11.html

Ihre Ansprechpartnerin:

Fresenius Kabi Austria GmbH

Mag.a (FH) Waltraud Götschl

Estermannstraße 17

4020 Linz Das Mindestentgelt für die Stelle als Quality Assurance Specialist/Quality Operations (m/w/d) beträgt 40.000,00 EUR brutto pro Jahr auf Basis Vollzeitbeschäftigung. Bereitschaft zur Überzahlung.

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