Quality Assurance Specialist

4 days ago

Solihull, Solihull, United Kingdom Guerbet Full time
Job Title: Quality Assurance Officer

We are seeking a highly skilled Quality Assurance Officer to join our team at Guerbet. As a Quality Assurance Officer, you will play a critical role in ensuring compliance with legislative requirements and maintaining our Wholesale License (WDA) by adhering to Good Distribution Practice (GDP) standards.

Key Responsibilities:
  • Manage the UK Quality Management System (QMS) and ensure it meets all requirements of the scope of our business, as well as alignment with the corporate QMS where required.
  • Ensure the QMS meets the requirements of ISO9001 and manage the relationship with the certification partner.
  • Perform internal audits of business functions, in line with agreed schedules.
  • Lead and document the Management Review process.
  • Oversee significant changes as part of the Change Control process.
  • Lead resolution of arising issues using the Corrective and Preventative Actions process.
  • Implement a local Environmental Management System (EMS) that meets ISO14001 standards.
  • Implement a local Information Security Management System (ISMS) that meets ISO27001 standards.
  • Manage the company medical device products on the Medical Device Register.
  • Support Medical Affairs Manager and Corporate RA with arising issues.
  • Attend monthly meetings with 3rd Party RA Partner.
Requirements:
  • Sufficient experience and qualifications in GDP and QMS.
  • Good knowledge of administrative tasks.
  • Good competencies in contrast media and medical devices are an asset.
  • Fluent in English.
  • Analytical skills and attention to detail.
  • Ability to work independently and as part of a team.
  • Self-motivated and responsible.

Guerbet is an Equal Opportunity Employer. We believe that no individual should be discriminated against because of their differences, which includes age, disability, ethnicity, gender, gender identity and expression, religion, or sexual orientation. All employment decisions shall be made without regard to age, race, creed, color, religion, sex, national origin, ancestry, disability status, veteran status, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status, or any other basis as protected by federal, state, or local law.

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