Experienced QA Professional for digital and automated systems validation
4 days ago
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Experienced QA Professional for digital and automated systems validationCategory: Quality
Location: Hillerød, Capital Region of Denmark, DK
Are you motivated by regulatory requirements and automated processes to produce, test and launch important medical devices and combination products? Do you want to join our team which is expanding into a new and exciting Finished Product Manufacturing area? Ready to set compliance direction and advise colleagues across the organization?
If you're ready to take on this challenge and thrive in a collaborative team environment, apply now to join our team at Finished Product Manufacturing Science & Technology QA (FPMSAT QA) in Hillerød.
The position
We are currently expanding our automated and digitalized facilities across all production phases, both locally and globally. As a QA Professional within FPMSAT Product Control & Innovation QA, you will join a dynamic team that sets the compliance direction for operations in transportation, intralogistics, laboratories, testing equipment, testing methods, digital solutions, robotics, and automation.
This role offers a unique opportunity to work at the forefront of digital development, machine learning, and simulation models, ensuring the highest quality and innovation.
Among other key responsibilities, you will:
- Set the compliance direction for projects, production-related activities, and maintenance to ensure adherence to relevant regulatory and internal requirements.
- Impact a broad range of crucial processes to deliver products to patients.
- Handle documentation, deviations, Change Control, Validation Activities, and possibly new suppliers while supporting departments in Line of Business with regulatory requirements and compliance discussions.
- Support the area of establishing various Digital/IT solutions for future automation and digitalization.
- Support the area of setting requirements for intralogistics that affects Novo Nordisk globally.
In this role, you will be able to handle situations independently, apply your subject matter knowledge, identify better practices, create improvements to processes, share knowledge, and let your colleagues learn and shine.
Finally, you will find solutions through a solid process and business understanding and give proactive advice to our stakeholders to secure we establish simple compliant solutions within processes such as digital solutions, intralogistics, and transportation.
Qualifications
To succeed in this role, you have:
- A master’s degree within engineering, medicine and technology, pharmacy, chemistry, science in transport & logistics, or similar.
- Experience within QA roles.
- Experience within Computerized Systems validation.
- Preferably have experience with process automation and digitalization.
- Fluency in writing and speaking English.
It will be seen as an advantage if you have knowledge of medical device manufacturing, GMP, LEAN methodologies, GAMP5 guidelines, GxP for AI/Machine Learning applications, and intralogistics/transportation validation.
On a personal level, you have outstanding stakeholder management skills and are well-structured in your approach to tasks, thorough and efficient in execution of responsibilities. Your colleagues in QA, much like in the rest of Novo Nordisk, are diverse in gender, nationalities, and levels of experience, so an inclusive, respectful mindset is a must-have.
About the department
At FPMSAT QA, we are a team of highly qualified professionals based at our Hillerød site, with diverse backgrounds and interests. We are responsible for ensuring the quality and compliance of all processes in FPMSAT, including product development and life cycle management, design control, testing, manufacturing development, and manufacturing processes.
We take pride in our work and are constantly seeking to improve our competencies and processes through a focus on simplicity and collaboration. By joining our team, you will have the chance to make a real difference in the lives of patients through the development and life cycle management of crucial medical devices. We share an informal tone, great work morale, and tall ambitions to be the best at what we do. With a healthy sense of humor and a can-do attitude, you will fit right in.
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.
Deadline
5 January 2025
We will review applications received on an ongoing basis, so do not hesitate to apply today.
You do not need to attach a cover letter to your application, but please include a few sentences about why you are applying in your resume or CV. To ensure an efficient and fair recruitment process, please refrain from adding a photo in your CV.
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 the communities we operate in. Together, we’re life-changing.
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