Senior Quality Assurance Officer

4 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 Senior Quality Assurance Officer to join our team.

Main Responsibilities:

  • Support and improve the Quality Management System (QMS) employed by Norgine, Hengoed, and promote continuous improvements while maintaining compliance with regulations and standards for medicinal products and medical devices.
  • Manage and perform internal self-inspections and external audits, including vendors and suppliers, for commercial and investigational medicinal products.
  • Support the Qualified Person (QP) in the execution of their legal and routine duties.
  • Provide support to site projects.
  • Maintain key Quality documents, including the Site Master File.
  • Ensure the provision of validation advice and support to site initiatives as required.
  • Support the ONE Norgine model, particularly with regards to Quality.
  • Support the delivery of site Quality objectives and support of wider business objectives.
  • Creation of Quality agreements.
  • Responsible for the Quality oversight of Pharmaceutical Development.
  • Responsible for the direct line management of Quality teams, including Quality Officers and Quality Technical Administrators, and the performance management and individuals' developments.

Key Responsibilities & Accountabilities:

  • Perform delegated duties of the QP.
  • Direct Quality Assurance Officers and Quality Technical Administrators.
  • Generation of key performance indicators.
  • Maintenance and improvement of QMS.

Requirements:

  • A degree or equivalent in a science or engineering subject is preferred.
  • A minimum of 5 years relevant experience in a Quality environment in the pharmaceutical industry.
  • Line management experience.
  • Strong communication and supervisory skills are essential.
  • The ability to introduce, co-ordinate, 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.

Benefits:

Norgine offers a range of benefits to its employees, including a competitive salary, comprehensive benefits package, and opportunities for professional development and growth.



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