Quality Assurance Specialist

6 days ago

Metropolitan Borough of Solihull, United Kingdom Guerbet Full time
Job Title: Quality Assurance Specialist

Guerbet is a global leader in medical imaging, offering a comprehensive portfolio of pharmaceuticals, medical devices, digital, and AI solutions for diagnostic and interventional imaging. We are seeking a Quality Assurance Specialist to join our team in the UK.

Job Summary:

The Quality Assurance Specialist will be responsible for ensuring compliance with legislative requirements, maintaining the company's Wholesale License (WDA), and managing the UK Quality Management System (QMS). This role will also involve implementing and maintaining a local Environmental Management System (EMS) and Information Security Management System (ISMS).

Key Responsibilities:
  • Ensure compliance with GDP requirements and maintain the company's Wholesale License (WDA)
  • Manage the UK Quality Management System (QMS) and ensure it meets all requirements
  • Implement and maintain a local Environmental Management System (EMS) and Information Security Management System (ISMS)
  • Perform local administrative actions to maintain the UK users and training of the Company LMS: ComplianceWire
  • Manage the company medical device products on the Medical Device Register and support Medical Affairs Manager and Corporate RA with arising issues
  • Support Medical Affairs Manager with pharmacovigilance-related tasks
Requirements:
  • Good understanding of GDP and QMS requirements
  • Experience in implementing and maintaining EMS and ISMS
  • Excellent communication and organizational skills
  • Fluent in English
What We Offer:

Guerbet provides a dynamic and multicultural work environment, with opportunities for professional growth and development. We offer a competitive salary and benefits package, as well as a chance to work on exciting projects that make a real difference in people's lives.

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