Manager Compliance leading GMP compliance team at Wasserburger Arzneimittelwerk GmbH. Ensuring compliance with pharmaceutical regulations while fostering teamwork and quality standards.
Responsibilities
Fachliche und disziplinarische Leitung eines GMP-Compliance-Teams
Verantwortung für die GMP-konforme Bearbeitung von CAPAs, Änderungsverfahren und Reklamationen
Verantwortung für Dokumenten-, Trainingswesen und Lieferantenqualifizierung
Verantwortlich für Selbstinspektionen und Management Review
Initiierung und Leitung bereichsübergreifender Verbesserungsprojekte
Bereitstellung relevanter KPIs
Leitung und Mitwirkung bei bereichsübergreifenden Projekten, Audits, Inspektionen und sonstigen GMP-relevanten Aufgaben
Requirements
Abgeschlossenes natur- oder ingenieurwissenschaftliches Studium oder vergleichbare Qualifikation
Mehrjährige Berufserfahrung in der pharmazeutischen Industrie, idealerweise mit Führungsverantwortung im GMP-regulierten Umfeld
Fundierte Kenntnisse der pharmazeutischen Regularien (GMP, AMWHV, AMG)
Strukturierte, verantwortungsbewusste Arbeitsweise und Freude an Teamführung
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