Aktuelle Jobs im Zusammenhang mit Qualification Specialist - Biberach - bertrandt


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  • GMP Specialist

    vor 3 Wochen


    Biberach an der Riß, Baden-Württemberg, Deutschland GULP – experts united Vollzeit

    **About GULP – experts united**We are a dynamic company seeking a highly skilled GMP Specialist to join our team. As a GMP Specialist, you will play a crucial role in ensuring the quality and compliance of our pharmaceutical products.**Key Responsibilities**Provide project support and consulting services, including all GMP aspects, to ensure compliance...

Qualification Specialist

vor 3 Monaten


Biberach, Deutschland bertrandt Vollzeit

Was Sie erwartet: Validierung und Qualifizierung der technischen Gebäudeausrüstung inklusive zugehöriger computerisierter Systemen und DokumentationUnterstützung der Fachbereiche im Bereich der Raumqualifizierung inklusive Steuerung der QualifizierungstätigkeitenKoordinierung und Monitoring der internen und externer Validierungs- und QualifizierungsaktivitätenUnterstützung der Fachingenieure bei Fragen zu Validierung und Qualifizierung sowie zu Systemen wie GoTrack. Überwachung von GxP-Themen im GoTrack-SystemErstellung und Nachverfolgung von ÄnderungsanträgenMitwirken 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 BerufserfahrungBerufserfahrung in der Validierung von technischer Gebäudeausrüstung im regulatorischen GxP-UmfeldUmfangreiche Kenntnisse der allgemeinen Vorschriften EU-GMP-Leitfaden, etc.Langjährige Erfahrung im GMP Produktions- oder Laborumfeld, idealerweise im Bereich Analytik oder Geräte/AnlagenqualifizierungFundierte Kenntnisse zum Thema Data Integrity sowie Kenntnisse in Computervalidierung und DokumentenmanagementAusgeprägte Kommunikations-, Präsentations- und ModerationsfähigkeitAusgeprägtes Organisationstalent und TeamfähigkeitSehr gute PC-Kenntnisse in den gängigen MS Office AnwendungenFließende 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