Clinical Trial Quality Assurance Specialist
About the Role: We are seeking a highly skilled Clinical Trial Quality Assurance Specialist to join our team on a permanent basis. As a key member of our Medicines Quality Organisation, you will be responsible for ensuring the quality and integrity of our clinical trials.
Key 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.
* 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 corrective/preventive actions (CAPA) including review/approval as necessary.
* Provides input into risk assessments, audit planning, and/or quality plans based on identified signal/risks/gaps.
* Complete self-inspections and drive improvements that are meaningful and actionable.
* Ensure local implementation of the quality systems as necessary.
* Provides support related to external party management (for example, third-party organizations, business alliance partners) as assigned.
Requirements:
* Bachelor's Degree in a science/technology/healthcare-related field or equivalent work experience.
* Demonstrated ability to apply quality systems within a regulated work environment.
* Experience in a quality control/quality assurance role.
* Experience in defined functional business areas, for example, medical writing, regulatory affairs, or clinical trial management.
* Effective project and time management skills.
* Demonstrated ability to communicate effectively, both written and verbal, and to influence others.
* Demonstrated ability to prioritize and handle multiple concurrent tasks.
* Strong interpersonal skills with demonstrated flexibility in varying environments/geographies.
* Effective organization/self-management skills.
* Ability to work independently and as part of a team.
About Us: Our company is a global leader in pharmaceuticals, committed to delivering innovative solutions that improve patient outcomes. We offer a dynamic and supportive work environment, with opportunities for professional growth and development.