Quality Assurance Specialist
1 month ago
We are a global leader in medical imaging, offering a diverse portfolio of pharmaceuticals, medical devices, digital, and AI solutions for diagnostic and interventional imaging. Our commitment to innovation has led us to dedicate 10% of our revenue to Research & Development, aiming to improve diagnosis, prognosis, and quality of life for patients.
Achieve, Cooperate, Care, and Innovate are the core values that guide our daily practices. As a pioneer in contrast products for 95 years, we continuously strive for excellence.
Working at Guerbet means being part of a multicultural team of 2,600 people across more than 20 countries, contributing to the future of medical imaging.
Key Responsibilities:
Quality Assurance: Ensure compliance with legislative requirements to maintain the Wholesale License (WDA) by adhering to Good Distribution Practice (GDP). Manage the UK Quality Management System (QMS) and report to the Medical Affairs Manager.
- Implement and maintain a quality management system.
- Focus on managing authorized activities and ensuring the accuracy and quality of records.
- Develop and maintain initial and continuous training programs.
- Effectively handle relevant customer complaints.
- Perform self-inspections at regular intervals and implement necessary corrective measures.
Quality Management System (QMS):
Manage the local QMS, ensuring it meets company requirements and aligns with the corporate QMS where necessary. Lead and document the Management Review process.
Learning Management System (LMS) Administration:
Perform local administrative actions to maintain UK users and training on the Company LMS: ComplianceWire.
- Ensure all UK users and training items are correctly created and maintained.
- Liaise with the global LMS manager over arising issues and training.
Implement a local EMS that meets ISO14001 standards.
Information Security Management System (ISMS):
Implement a local ISMS that meets ISO27001 standards.
Additional Responsibilities:
Regulatory Affairs:
- Manage company medical device products on the Medical Device Register.
- Support the Medical Affairs Manager and Corporate RA with arising issues.
- Good competencies in contrast media and medical devices are an asset.
- Fluent in English. Guerbet provides accommodations to applicants and employees with disabilities.
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