Data Integrity Steward (Denmark, Hillerød)

Jobbeskrivelse
Placering
Hillerød, Denmark

Jobkategori
Manufacturing

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Are you passionate in the process of ensuring data integrity, data compliance and validate audit trail assessments? Do you want to be part of a “Factory of the Future”? Join us and play a key role in ensuring the validated state of our production equipment.

Apply for a life changing career!

The Position
As a Data Integrity Steward you will be part of PS AM Site Hillerød Assembly Back Office.

The main tasks will be to:

• Ensure that our Assembly equipment is in compliance with the regulatory requirements and company procedures for Data Integrity.
• Conduct audit trail assessments, data flows, risk assessments, validation etc.
• Work closely with Assembly validation team and IT Responsible.
• Participate in process improvements, deviation handling etc.

Qualifications

• Ideally, IT or computer systems background with min. 3 years of experience.
• Experience with validation of Computerized Equipment and/or IT system.
• Proven experience with EudraLex annex 11 and/or CFR part 11.
• Experience with establishing data maps and data integrity risk assessments.
• Previous roles as System Manager or Validation Responsible.
• Strong GMP mindset – Quality in everything.
• Able to work in English at a professional level.

On a personal level, you should take responsibility for tasks to ensure their completion and their quality – be able to the one “driving” the task. You should be able to communicate effectively both verbal and in writing and you should be able to work in projects, smaller groups and solo.

Furthermore, you should be open-minded, building relationships on trust. You should also be curious and driven to achieve first-class results.

About the Department
The PS AM Site Hillerød Assembly Back Office is responsible for the assembly of Medical Devices for injection of medicine used for the treatment of Diabetes and Obesity. We handle high complex assignments, such as production improvements, implementation of new devices, and investigation and implementation of new technologies and machines for high volume production. Our focus is on ensuring compliance and the validated state.

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 energise 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
In case of questions – please contact Manager, Morten Bay Alexandersen -30790838.

Deadline
5th August 2024

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.