Role Overview:
As a GMP QA Consultant, 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 GMP and local regulatory requirements.
Key Responsibilities:
* Conduct internal and external audits of clinical trials to ensure compliance with GMP 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.