Validation Technical Writer

Are you passionate about quality management systems? Do you have a knack for writing and a keen eye for detail? We are looking for a Validation Technical Writer to join our Project Office, KFA (Koriyama Factory) team. If that sounds like you, read on and apply today for a life-changing career.
Novo Nordisk has been globally recognized as the Best Place to Work, topping the ranks for two consecutive years in 2022 and 2023. It is an exciting time to join Novo Nordisk and be part of a dynamic company in an even more dynamic industry, helping us achieve our aspirations to establish a global presence in the industry.

About the department
Novo Nordisk is a global healthcare company with more than 100 years of innovation in diabetes care. This heritage has given us experience and capabilities that also enable us to help people defeat obesity, hemophilia, growth disorders and other serious chronic diseases. Headquartered in Denmark, Novo Nordisk employs over 64,000 people in 80 countries, and markets our products in more than 170 countries.

The Project Office, KFA is involved in facility expansion, including equipment design, ensuring a high level of compliance with all internal and external regulations/requirements in all project activities. We collaborate with project engineers and validation specialists to grasp activities and prepare project-related documentation. Our team assists with the development of processes and procedures for project-related activities, living up to Novo Nordisk Way, Essentials, and the Triple Bottom Line. The job is based in Koriyama, Fukushima, and our dynamic team is committed to excellence and innovation.

The position
As a Validation Technical Writer at Novo Nordisk, you will:

• Involvement in facility expansion, including equipment design, and ensuring high compliance with internal and external regulations in all project activities.
• Collaboration with project engineers and validation specialists, and assistance in developing processes and procedures for project-related activities.
• Commitment to upholding the corporate values and principles.
• Establishment of quality/validation documentation with the project team, reviewing supplier-provided designs and documents, and management of quality documents as an author/writer.
• Active participation or support during audits or inspections.

Qualifications

• Bachelor’s degree.
• Over 2 years of experience working with quality systems.
• Knowledge of Validation (VPL, DR, DQ, IOP/Q, Risk assessment) with familiarity with Japanese regulations (GMP, etc.), ISO9001, PIC/S, CSV, and relevant laws
• Proficiency in general Quality Management System.
• Proficient in Japanese and English communication; essential writing skills in English.

Working at Novo Nordisk
We are a proud life-science company, and life is our reason to exist. We’re inspired by life in all its forms and shapes, ups and downs, opportunities and challenges. For employees at Novo Nordisk, life means many things – from the building blocks of life that form the basis of ground-breaking scientific research, to our rich personal lives that motivate and energize us to perform our best at work. Ultimately, life is why we’re all here - to ensure that people can lead a life independent of chronic disease.

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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