QA Product Specialist

Overview

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.

Job Purpose

To provide QA support and CMO oversight for the manufacture of Kyowa Kirin’s products in order to ensure that each product is manufactured and supplied to the marketplace in compliance with (c)GMP requirements, Marketing Authorizations, company operating policies and procedures and business requirements.

Responsibilities

Key Responsibilities:

• Review non-conformances, process deviations, and product complaints to ensure root causes are identified and corrective actions are implemented.
• Manage GMP document changes, validation protocols, stability programs, and batch record reviews to maintain compliance.
• Facilitate QP certification process by reviewing batch documentation, deviation investigations, and change controls.
• Participate in project meetings, conduct Product Quality Reviews, and ensure continuous improvement in GMP compliance.
• Maintain Technical (Quality) Agreements and oversee quality-related activities at CMOs.
• Provide regular performance reports to QA management and ensure adherence to company policies, including Data Integrity.
• Support the establishment and maintenance of KKI’s QMS in compliance with global regulatory standards.
  
  

Qualifications

Position Requirement:

• Life Science degree (HBO/WO) or equivalent, with at least few years of pharmaceutical experience.
• Strong understanding of pharmaceutical manufacturing, distribution, and GMP guidelines.
• Experience in secondary packaging and batch certification; familiarity with aseptic processes is advantageous.
• Experience in supporting batch certification.
• Knowledge of Quality Systems, including deviations, CAPAs, and Change Control.
• Strong interpersonal, communication, analytical, and problem-solving skills.
• Detail-oriented, self-motivated, and capable of working in a virtual pharmaceutical environment.
• Fluent in English, Written and spoken
  
  

Kyowa Kirin International is an equal opportunities employer. No agencies please.