Senior QMS Specialist

Overview

Senior Quality Management System Specialist

at Kyowa Kirin International plc

Spain or Italy or UK

 

WE PUSH THE BOUNDARIES OF MEDICINE.

 

LEAPING FORWARD TO MAKE PEOPLE SMILE

 

At Kyowa Kirin International (KKI), our purpose is to make people smile. This means more than drug discovery and development; it is about embedding care into everything we do to make a difference every day for those that need it most. We’re an inclusive pharmaceutical company that takes time to understand what really matters to our patients, their families, and their healthcare professionals, helping our people to take bold actions that deliver life-changing solutions sooner. Our culture is rooted in our values: Teamwork, Commitment to Life, Innovation, and Integrity. They help us to push boundaries to deliver extraordinary impact and make KKI a brilliant place to work.

Responsibilities

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, CAPA and Complaints Management and Self- Inspections performance.

 

This role can be based in Spain, Italy or UK

 

Key Responsibilities:

• Demonstrate expert knowledge of the KK QMS and its application to KK GxP licence compliance and product supply requirements.
• Support appropriate level of QMS GxP documentation reviews are carried out within KK, as necessary, to ensure ongoing QMS compliance.
• Act as Business process lead (BPL) who supports the Business process owner (BPO) and acts as regional representative for Veeva systems (Deviation/CAPA and Complaints).  Accountable for ensuring global requirements that have been established are implemented.  
• Support QMS processes across EMEA, including delivering QMS training, as necessary, to ensure that staff are kept abreast of current Kyowa Kirin QMS requirements.
• Ensure global policies and procedures are incorporated within the EMEA QMS as appropriate.
• 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.
• Ensuring all work is conducted in accordance with the company policy for Data Integrity.

Qualifications

• Life Science Degree with significant level of experience
• Specialist knowledge or experience of pharmaceutical QMS processes and practices.
• A broad experience of working within the pharmaceutical industry operating in a Senior Quality Assurance position at a manufacturing/distribution site.