IT Quality Professional, Koriyama Factory

Category:  Quality
Location: 

Koriyama, Fukushima, JP

   

At Novo Nordisk, we aim to make a difference. For nearly 100 years, we have led the way in diabetes care. Being part of Novo Nordisk allows our employees to embark on life-changing careers, and the opportunity to help improve the quality of life for millions of people around the world.

 

At Koriyama Factory (KFA), our employees are passionate about what they do, knowing their jobs help make a difference to millions of people who rely on our products every day. After all, delivering medicines is a special accountability.

 

If you are keen on playing a crucial role in ensuring the quality of the processes, come join Novo Nordisk and help us make what matters.

 

 

About the Department

 

Novo Nordisk Koriyama Factory (KFA) ensures the continuous and stable supply of high-quality pharmaceutical products.  This is a newly created position at the KFA QA team which will focus on IT Quality.  You will be responsible for quality assurance and quality advice accountable for IT systems in KFA while collaborating with the global team daily. 

 

 

The Position

 

As the only IT Quality Professional of the quality assurance team, you will be accountable to assist and advice on initiatives related to IT system qualification and compliance. Participate and contribute in audit and inspections as IT and Quality advisor. Guide Process Confirmations along with existing quality assurance oversight activity and participate in relevant cross functional Novo Nordisk initiatives and projects relating to IT systems.

 

Other role tasks are as follows, but are not limited to:

 

 

  • As IT quality assurance for system, handle and approve Deviations and change requests related to IT systems. Identify compliance issues and take initiative to having them closed timely. Give input and guidance in relations to quality evaluations and other quality ensuring tasks.

 

  • Contribute to validation planning, including IT risk management and conclusion of appropriate validation strategy. Review and approve key deliverables according to validation planning. Establish and maintain quality oversight related to the system or services to ensure compliance with internal and external requirements in collaboration with IT System Owner.

 

  • Assist SOP (Standard Operating Procedures) content accountable to remove unnecessary complexity in process and IT related documents. Partner with Novo Nordisk Quality to drive initiatives to improve IT qualification and maintenance practices in Novo Nordisk.

 

  • Preparation of documentation related to IT systems and presentation in audit and inspections. Participate in follow up of findings and development of action plans when related to IT systems.

 

 

  • Represent Quality in relevant projects and contribute to finding the right solutions. Provide Quality and IT expertise during projects in Koriyama Factory. Ensure excellent collaboration within stakeholders in the organisation. Participate as quality assurance in digitalization projects both in KFA and in global.

 

Qualifications

 

  • At least 5 years of experience in working with the IT systems such as SAP, MHS or LIMS
  • Experience with quality standards within IT systems (validation experience is a must) and experience working at factory
  • Knowledge of Japanese IT requirement “コンピュータ化システム適正管理ガイドライン” and experience with general standards (GMP and ISO, specifically ISO9001 and ISO13485) are preferred
  • Fluent English (written and spoken) is required and basic level of Japanese or experience working in Japan is required
  • Driver's lincence is a must, as commuting by a car is required (non-Japanese Driver's Licence is ok)

 

 

Working at Novo Nordisk

 

At Novo Nordisk, we don’t wait for change. We drive it. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development, through to manufacturing, marketing, and sales – we’re all working to move the needle on patient care.

 

Contact

Please send your CV online (click on Apply and follow the instructions).

 

Deadline

We will review your applications as you apply!

 

 

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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