Digital QA Expert for Automated Systems and Validation
7 days ago
We are seeking a highly skilled Digital QA Expert to join our team in Hillerød, Denmark.
Job DescriptionThe successful candidate will be 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.
Key Responsibilities:- 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.
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.
Estimated salary: €85,000 - €110,000 per year, depending on qualifications and experience.
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