Clinical Trial Quality Representative
Our client, a global pharma organisation, is currently recruiting for a Clinical Trial Quality Representative to join their Medicines Quality Organisation (MQO) team on a permanent basis. This role requires experience working with Clinical Trials and Quality Management Systems. It is a Senior Associate/Principal Associate level position offering hybrid working. A detailed role profile is available upon request.
Responsibilities
* Contribute to the development of area-specific procedures and required tools, resource documents, and supplemental materials, including review and content approval of quality system documents. Ensure regional and/or affiliate quality system requirements have clear accountabilities.
* Recommend new quality system documents or changes to existing ones where applicable.
* Advise on appropriate training for implementation and documentation.
* Provide consultation on the interpretation and practical application of external requirements, standards, and procedures.
* Responsible for deviations, change controls, Notification to Management (NTM), ensuring events are appropriately documented, escalated, and completed.
* Consult on root cause analysis and CAPA, including review/approval as necessary.
* Provide input into risk assessments, audit planning, and quality plans based on identified signals, risks, or gaps.
* Complete self-inspections and drive meaningful, actionable improvements.
* Ensure local implementation of quality systems as necessary.
* Support external party management, such as third-party organizations and business alliance partners, as assigned.
Requirements
* Bachelor’s Degree in a science, technology, healthcare-related field, or equivalent work experience.
* Ability to apply quality systems within a regulated environment.
* Experience in quality control or assurance roles.
* Experience in functional areas like medical writing, regulatory affairs, or clinical trial management.
* Effective project and time management skills.
* Strong communication skills, both written and verbal, with the ability to influence others.
* Ability to prioritize and handle multiple tasks concurrently.
* Flexible interpersonal skills suitable for varying environments and geographies.
* Strong organizational and self-management skills.
* Ability to work independently and collaboratively.
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