Senior QA Product Specialist

Overview

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.

Job Purpose:

Join our dynamic team at Kyowa Kirin International as a Senior QA Product Specialist!

Ensuring our products meet the highest standards of quality and compliance with cGMP requirements, Marketing Authorisations, and company policies, you’ll be a key player in delivering excellence to the marketplace while driving our business forward

Responsibilities

• Demonstrate expertise in KKS QMS and its application to GxP product supply.
• Manage QA aspects of complex situations autonomously, seeking advice when needed.
• Facilitate prompt and professional communication of key issues to management for effective collaboration and resolution.
• Influence project management meetings to ensure product quality and GMP compliance.
• Prepare and maintain Technical (Quality) Agreements with third-party organizations, clearly defining roles and responsibilities.
• Conduct GxP documentation reviews at CMO facilities and within KKS to ensure compliant product release.
• Regularly review and implement corrective and preventative actions (CAPAs) within suitable timeframes.
• Train staff on GxP activities, including refresher training, to keep them updated on current regulations.
• Provide regular reports of key performance indicators to QA management for resource allocation and corrective actions.
• Participate in the review and recall of defective products to minimize patient risk.
  
  

Qualifications

Academic Success

Life Science degree or equivalent.

Pharma Pro

Specialist knowledge or experience in pharmaceutical manufacturing, supply, or distribution processes.

GxP Guru

Excellent working knowledge of international GxPs, especially MHRA and FDA requirements.

Aseptic Ace

Previous quality experience at aseptic manufacturing facilities (bonus points for biologics or monoclonal antibody manufacturing).

QC Whiz

Sound knowledge of QC and stability chemical analytical testing techniques for solids, semi-solids, and parenteral products.

Validation Virtuoso

Familiar with regulatory requirements for validation activities in manufacturing, packaging, analytical methods, cleaning procedures, and computerized systems.

Regulatory Rockstar

Familiar with EU Directives, EU and USA regulatory processes, and ICH Guidelines.

QMS Expert

Familiar with Quality Management Systems like ICH Q10.

Ready to bring your expertise to our team? Apply now and let’s make a difference together!

If you require any additional support through the interview process, you can raise this in complete confidence. Agency Information

We do not accept unsolicited CVs or resumes from recruitment agencies or search firms. We politely request that you do not approach our teams or managers on this basis.

KKI does not welcome any unsolicited calls or communication.

Kyowa Kirin International is an equal opportunities employer.