Validation Responsible

In Novo Nordisk, we have a passion for improving patients’ lives all over the world, and we are therefore expanding our API Manufacturing capacity in Kalundborg. Will you help us bringing that passion to life, by taking part of this large and complex project? Would you like to further develop your expertise within validation and quality control? And would you like to work in a dynamic team consisting of IT/Automation experts, project manager and validation experts? We are looking for a Validation responsible to help drive the compliance and validation activities in Novo Nordisk. Apply now to become part of the M3 IT/Automation department!

The Position
As a validation responsible you will be responsible for defining the validation strategy, validation planning and reporting in relation to a specific implementation of an IT system or computerized equipment with GxP (healthcare) impact. You will work closely with Line of Business (LoB) and other stakeholders to understand the the scope of validation and act as liaison with IT & automation team, process areas, QA and the project validation department.

Your key tasks will include:
• Participating in large scale expansion projects as the IT/automation validation expert thus responsible for execution of validation and quality control activities
• Taking responsibility for validation activities for the project(s) e.g., planning, documentation, coordination, and reporting and ensuring that these are executed effectively.
• Helping to develop and optimize our approach to validation and quality control work, ensuring we verify and validate the right things at the right level, supporting a risk-based approach to verification.
• Being responsible for performing various assessments such as Supplier Assessment and IT risk assessment or facilitating the workshops for these activities.
• Ensuring the validated state of the system(s) by performing periodic reviews, addressing deviations, creation and maintenance of system documentation and instructions in corporation with the system managers and IT responsible when needed and that systems are following relevant internal and external regulatory requirements.
• Working as a validation sparring partner for our IT/Automation & process experts to ensure the correct level of quality throughout the project

Qualifications
To be successful in this role, you will need the following requirements:
• GxP compliance experience, preferably also in working with GAMP (Good Automated Manufacturing Practice).
• 2-5 years of experience within validation from the pharma industry or other regulated industries.
• Experience in working with validation of process, computerized equipment or IT systems
• Quality mindset with good ability to execute within deadlines is essential.
• It will be considered an advantage, if you have experience within IT/OT
• Stakeholder management, facilitation and communication skills.

You are proactive and thrive in a challenging, dynamic, and ever-changing environment. You can handle several tasks at a time and keep an ongoing focus on results. Being open minded and positive and have the ability and feel confident to collaborate with external parties, customers, vendors, and consultants. In addition, you must have strong work ethic and willingness to take responsibility and drive success.

About the Department
Today, 3,200 employees of Novo Nordisk Kalundborg produce half of the world’s insulin and a number of biopharmaceutical products. With more than 50 years of expertise in large-scale biotech manufacturing, we are the world’s largest insulin-producing facility. By joining Novo Nordisk Manufacturing in Kalundborg, we promise you a developing career, where you will be met with trust and responsibility by dedicated colleagues with diverse backgrounds in a successful company with a higher purpose and an inclusive environment. Together, we make a difference every day for more than 30 million people living with diabetes and other chronic diseases. This is your opportunity to be part of our exciting journey. 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
For further information, please contact project manager Khalid Rafique +45 3039 4250 or hiring manager Dorthe Kofod Schjerning +45 3079 8057.

Deadline
20 March 2024 Applications will be reviewed 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.
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.