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Compliance Specialist (f/m/d)

Job Details

Zusammenfassung

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Job Details

Ihre Aufgaben

  • Support GxP compliance of all activities in the clinical trial supply management, drug-related distribution and storage
  • Responsibility for the project-related GxP documentation and maintenance of lists
  • Operational support and independent performance of operational tasks as process expert in the IMP GxP Compliance Team across diverse clinical trials and R&D Programs (e.g. Batch Record Reviews and TMF Filing)
  • Establish and maintain inspection readiness for clinical trial supply activities and support in preparing, accompanying and following up on audits and inspections
  • Optimization of processes and workflows (e.g. support in the creation and review of SOPs and other GxP related documents)

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