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Qualification Specialist
vor 3 Wochen
Was Sie erwartet:
Validierung und Qualifizierung der technischen Gebäudeausrüstung inklusive zugehöriger computerisierter Systemen und Dokumentation Unterstützung der Fachbereiche im Bereich der Raumqualifizierung inklusive Steuerung der Qualifizierungstätigkeiten Koordinierung und Monitoring der internen und externer Validierungs- und Qualifizierungsaktivitäten Unterstützung der Fachingenieure bei Fragen zu Validierung und Qualifizierung sowie zu Systemen wie GoTrack. Überwachung von GxP-Themen im GoTrack-System Erstellung und Nachverfolgung von Änderungsanträgen Mitwirken bei der Abarbeitung von CAPA-Maßnahmen
Was Sie mitbringen:
Abgeschlossenes naturwissenschaftliches Studium (Master) der Fachrichtungen Pharmatechnik, Chemie- oder Verfahrenstechnik mit mehrjähriger Berufserfahrung oder abgeschlossene Berufsausbildung als Chemielaborant*in, Biologielaborant*in, Techniker*in oder im IT-Bereich bzw. vergleichbare Qualifikation mit langjähriger Berufserfahrung Berufserfahrung in der Validierung von technischer Gebäudeausrüstung im regulatorischen GxP-Umfeld Umfangreiche Kenntnisse der allgemeinen Vorschriften EU-GMP-Leitfaden, etc. Langjährige Erfahrung im GMP Produktions- oder Laborumfeld, idealerweise im Bereich Analytik oder Geräte/Anlagenqualifizierung Fundierte Kenntnisse zum Thema Data Integrity sowie Kenntnisse in Computervalidierung und Dokumentenmanagement Ausgeprägte Kommunikations-, Präsentations- und Moderationsfähigkeit Ausgeprägtes Organisationstalent und Teamfähigkeit Sehr gute PC-Kenntnisse in den gängigen MS Office Anwendungen Fließende Deutsch- und Englischkenntnisse in Wort und Schrift
Was wir können:
Mobiles Arbeiten Flexible Arbeitszeiten Trainingsangebote Rabatte Mitarbeiter-Events Betriebliche Altersvorsorge und BU-Versicherung Mobiles Arbeiten Flexible Arbeitszeiten Trainingsangebote Rabatte Mitarbeiter-Events Betriebliche Altersvorsorge und BU-Versicherung
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