Quality Management System Specialist

WE PUSH THE BOUNDARIES OF MEDICINE.

LEAPING FORWARD TO MAKE PEOPLE SMILE

Everything we do at KKI, is rooted in the idea of leaping forward to make people smile. We are committed to innovation, for the benefit of the patients who count on us to support them. From medicines for rare and underserved diseases, to the support families need when facing a life-changing diagnosis – our team is proud of all we deliver, but also humble in knowing how much more needs to be done. By listening to patient stories, we gain a better understanding of the obstacles patients and their families face – so we can work to better meet their unique needs. The real proof of our impact is in the smiles we see on patients’ faces, when we have helped answer a need, or improved their well-being through our work. While the journey is not easy, it is one that is filled with purpose.

Job Purpose

To participate in the implementation, execution, delivery and maintenance of the EMEA GxP Quality Management Systems and be the subject matter expert in the KK QMS. Key areas of interest for this individual will be taking responsibility for Deviation Management and Self- Inspections scheduling and performance.

Key Responsibilities:

• Demonstrate operational knowledge of the KK QMS and its application to KK GxP licence compliance and product supply requirements.
• Key user on the electronic Quality Management System, including back up system administrator, where required.
• Support QMS processes across EMEA, including delivering QMS training and updating procedures, as necessary, to ensure that staff are kept abreast of current Kyowa Kirin QMS requirements.
• Act as the Business Process Lead for deviations, CAPA and the audit module within EMEA.
• Monitor and provide regular reports of key performance indicators to KK management, as part of the Quality System, so that the appropriate resources can be allocated and actions are implemented, as necessary.
• Other tasks required to support the activities of the team

Position Requirements

• Life Science Degree qualified with minimum 5 years’ experience
• Specialist knowledge or experience of pharmaceutical QMS processes and practices.
• A broad experience of working within the pharmaceutical industry operating in a manufacturing/distribution site.
• Excellent working knowledge of international QMS GxPs, especially in the interpretation of MHRA and FDA requirements, for the manufacture, control and distribution of commercial product and clinical trial materials
• Working knowledge of the regulatory requirements for validation activities as applied to computerised systems.
• Working knowledge of GxP requirements.
• Computer skills required (Word, Excel, PowerPoint etc.)

BENEFITS:

In return for your talent, we will provide support through smart working, adopting best practice, deploying the latest technology and ongoing personal development. Plus:

• Competitive salary
• Bonus
• Pension scheme
• Private medical insurance

To meet the expectations of our patients and to truly deliver on our Commitment to Life, we are continually looking for people who embrace this spirit. We are committed to providing a culture that offers both inspiration and reward – in terms of compensation and in work satisfaction. And in turn, we want people who’ll bring their unique ideas and diverse approaches, while also aligning to our ultimate goal of making people smile. If this sounds like a company that aligns with your values, we’d love for you to join us in our efforts.

kyowakirin.com/careers

Kyowa Kirin International is an equal opportunities employer.