Clinical Trials Quality Assurance Specialist
\
We are seeking an experienced Clinical Trials Quality Assurance Specialist to join our Medicines Quality Organisation (MQO) team on a permanent basis.
\
\
* Develop and implement area specific procedures and tools, including quality system documents.
\
* Recommend new quality system documents or changes to existing ones where applicable.
\
* Advise on training for implementation and documentation.
\
* Provide consultation on external requirements, standards, and procedures.
\
* Manage deviations, change controls, and notification to management, ensuring events are documented, escalated, and completed.
\
* Consult on root cause analysis and corrective/preventive actions (CAPA).
\
* Support risk assessments, audit planning, and quality plans based on identified risks.
\
* Lead self-inspections and drive improvements.
\
* Ensure local implementation of quality systems as necessary.
\
\
Requirements
\
\
* Bachelor's Degree in science/healthcare-related field or equivalent work experience.
\
* Demonstrated ability to apply quality systems in a regulated environment.
\
* Experience in quality control/quality assurance role.
\
* Effective project and time management skills.
\
* Strong interpersonal skills with flexibility in varying environments/geographies.
\