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    Reference number: 796158/1

    Dokumentationsmitarbeiter - Spezialist Produktion (m/w/d)

    Anstellung bei der Hays Professional Solutions GmbH
    Marburg
    • Bearbeitung und Verwaltung von Dokumenten in deutsch und englisch
    • Erstellen, Aktualisieren und Harmonisieren von behördenrelevanten Produktions-, Fertigungs- und Endfertigungsvorschriften für alle am Standort Marburg hergestellten und teilgefertigten Plasmaprodukte, rekombinanten Produkte und Lösungsmittel, Impfstoffe und Entwicklungsprodukte
    • Bereichsübergreifende Koordination und Überwachung aller Änderungsaktivitäten vor Stellen eines Änderungsantrages (CC) im Qualitätsmanagementsystem, sowie während des Änderungsantragsumlaufs und nach Genehmigung des CCs mit allen betroffenen Abteilungen (z.B. Produktion, QA, QP, QC, Validierung, GRA, Supply Chain, MES, LCM, R&D )
    • Erstellen und Bearbeiten von Änderungsanträgen (auch für Fremdfirmenmeldungen)
    • In Abstimmung mit z. B. QA, GRA, QP und Produktion: Entwicklung eines Einreichungs- und Implementierungsplans für Produktions- und Fertigungsvorschriften unter Berücksichtigung von Behördenanforderungen, internen Standards und Prozeduren sowie Abhängigkeiten zu weiteren, das gleiche Produkt betreffenden, Änderungen
    • Fachliche Mitarbeit in Projekten
    • Mitarbeit bei der Vorbereitung, Durchführung und Nachbereitung von internen und externen Inspektionen und Audits
    • Präsentation/Vorstellung der Produktions-/Fertigungsvorschriften, sowie der dazugehörigen Änderungsanträge und deren Aufbau und Struktur
    Online since: Fri Nov 29 14:20:25 CET 2024

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