
Clinical Trials Quality Assurance Specialist
2 weeks ago
Job Summary:
Certification and Batch Release of Clinical Trial SuppliesWe are seeking an experienced Clinical Trials Quality Assurance Specialist to serve as Qualified Person (QP) for the certification and batch release of clinical trial supplies in compliance with EU regulations.
Key Responsibilities:
- Serve as QP for clinical trial supplies, ensuring compliance with EU directives on Manufacturing/Importation Authorisation.
- Act as Responsible Person (RP) on Wholesale Distribution Authorisation (WDA) for Pre-Approval Access activities.
- Advise cross-functional teams on quality issue management, regulatory compliance, and continuous process improvement.
- Maintain and update Site Master Files and Manufacturing Authorisations.
- Escalate and communicate significant quality issues or deviations promptly to stakeholders and senior management.
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