Koriyama Novo Nordisk
The position

The role of the project quality control entails actively participating in the expansion of the facility as the Subject Matter Expert (SME) in Quality Control (QC), while advocating for KFA projects that align with future opportunities.

It involves continuously seeking opportunities to introduce new technologies by leveraging external knowledge for new facility and equipment implementations, all while ensuring strict compliance with both internal and external regulations.

Embracing the 'Circular for Zero' strategy for design and following the Novo Nordisk (NN) Way, Essentials, and Triple Bottom Line principles are integral aspects of this role.

Collaborate with NN Headquarters (HQ) to implement QC equipment meeting global requirements. Review supplier designs and estimates with QC team for lab and equipment specifications. Establish maintenance plans and transfer knowledge to KFA QC department.

Manage stakeholders, particularly the QC department, ensuring compliance with applicable requirements (Good x Practice (GxP), occupational health and safety, environment, etc.).

Ensure readiness for internal audits and regulatory inspections, act as Subject Matter Expert (SME) during audits, and oversee qualification and validation of new buildings, facilities, and equipment to maintain validated state, prioritizing quality, process performance, and employee safety.

Qualifications Bachelor's degree required. Experience as Quality Control at pharmaceutical company. Proficiency in Japanese regulations including PMD Act and GMP, as well as ISO, PIC/S, and CSV standards is preferred. Understanding of EHS, ISO, and OHSAS standards is desirable. Knowledge of drug product manufacturing processes, particularly in Quality Control, is essential. Business-level English and Japanese proficiency.

Working at Novo Nordisk Novo Nordisk is a leading global healthcare company with a -year legacy of driving change to defeat serious chronic diseases.

Building on our strong legacy within diabetes, we are growing massively and expanding our commitment, reaching millions around the world and impacting more than 40 million patient lives daily.

All of this has made us one of the 20 most valuable companies in the world by market cap. Our success relies on the joint potential and collaboration of our more than 63, employees around the world.

We recognize the importance of the unique skills and perspectives our people bring to the table, and we work continuously to bring out the best in them.

Working at Novo Nordisk, we're working toward something bigger than ourselves, and it's a collective effort. Join us Together, we go further. Together, we're life changing.

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