Quality Assurance Officer

3 weeks ago


Hengoed, Caerphilly County Borough, United Kingdom Norgine Full time

Transform Lives with Innovative Healthcare Solutions

Norgine is a leading healthcare organization that transforms lives with innovative healthcare solutions. We are seeking a highly skilled Quality Assurance Officer to join our team.

The successful candidate will be responsible for maintaining, supporting, and improving our Quality Management System (QMS) to ensure compliance with regulations and standards for medicinal products and medical devices. This will involve reviewing batch documentation, managing internal self-inspections and external audits, and supporting the Quality Person (QP) in their legal and routine duties.

Main Responsibilities:

  • Review batch documentation and associated deviations to ensure satisfactory completion prior to batch certification.
  • Maintain and improve the QMS to promote continuous improvements and compliance with regulations and standards.
  • Manage and perform internal self-inspections and external audits, including vendors and suppliers.
  • Support the QP in their legal and routine duties.
  • Maintain key quality documents, including the site master file, inspection evidence files, and quality-related SOPs.
  • Coordinate and perform investigations related to product quality complaints and liaise with market QMRs.
  • Supply information for, coordinate execution, and review of the Product Quality Review process.
  • Support the ONE Norgine model, particularly with regards to Global Quality.
  • Support the delivery of site quality objectives and support of Global Quality objectives.
  • Create Quality Agreements for commercial partners.

Requirements:

  • A degree or equivalent in a scientific discipline is preferred, with experience in a Quality environment in the pharmaceutical industry.
  • Strong communication skills are essential.
  • The ability to introduce, coordinate, complete, and report on projects.
  • A high level of self-motivation is necessary.
  • Attention to detail.
  • Able to rationally persuade.
  • Influencing skills.
  • Ability to perform audits, internally and externally.

About Norgine:

Norgine is a leading healthcare organization that transforms lives with innovative healthcare solutions. We offer a fully-rounded experience with no limits, where you can bring everything about yourself that you're proud of and get a sense of belonging, a long-term career with ongoing development and upskilling, and a company that cares about people's wellness as much as you do.



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