Senior Quality Assurance Officer
4 weeks ago
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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