Role Overview:
As a GCP QA Specialist, you will play a critical role in maintaining the integrity, quality, and compliance of clinical trials. You will conduct audits and monitor processes to ensure adherence to GCP, ICH guidelines, and local regulatory requirements.
Key Responsibilities:
- Conduct internal and external audits of clinical trials to ensure compliance with GCP, ICH guidelines, and applicable regulatory requirements.
- Review clinical trial documentation, including protocols, CRFs, informed consent forms, and regulatory submissions.
- Identify, document, and track deviations, non-compliance, and quality issues, and recommend corrective actions.
- Collaborate with clinical operations, regulatory, and medical teams to ensure high-quality trial conduct.
- Participate in vendor and site audits as required.
- Maintain QA documentation and prepare reports for management and regulatory inspections.
How to apply
If you are interested in this opportunity, please send your CV and a short cover letter highlighting your relevant experience. Applications will be handled in confidence and reviewed on a rolling basis.