Quality Control Project Staff, Koriyama Factory Expansion Project

Are you passionate about ensuring quality and compliance in manufacturing processes? Do you thrive in a fast-paced and expanding environment? We are looking for a Project Quality Control professional to join our team at Novo Nordisk. If you are ready for a new challenge and want to make a difference in the pharmaceutical industry, read on and apply today for a life-changing career.

About the department
At Novo Nordisk we are experiencing a rapid growth in sales over the recent years and along with the wide range of new products to be launched, we are re-enforcing our production capability world-wide.
As our Koriyama Factory (KFA) is also expanding its workforce, this exciting opportunity is now available for a Quality Control Staff, KFA in Japan to join one of the largest scale projects of the factory expansion (expanding the building, not just the equipment) by collaborating with the team members. Also, ensuring high level of compliance with all the internal and external regulations/requirements in all activities and readiness for new product launches as per defined milestones.

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 ISO9001, PIC/S, and CSV standards is preferred. Understanding of EHS, ISO14001, and OHSAS18001 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 100-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 63,000 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.

Contact
Upload your CV to our online career page (click on Apply and follow the instructions).

Deadline
Until the completion of recruitment.
Applications will be screened on an ongoing basis, so you are encouraged to apply as soon as possible.

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.

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