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As a Stability Specialist, you will be responsible for creating and maintaining stability and transportation studies, as well as supporting SVS and material change projects from a stability perspective.
Job Responsibility:
Support the maintenance of the existing product portfolio, SVS projects and material change initiatives
Handle non-conformances (infrequent, approximately one case every six months)
Support shelf-life extension activities for raw materials, intermediates and finished goods
Create and update stability and transportation documentation related to product changes
Set up stability studies, report on ongoing studies and keep the overall stability overview up to date
Participate in transportation studies and report on product performance within the documentation
Build and maintain strong collaboration with the Global Quality stability team in Denmark
Ensure proper documentation and follow-up of change requests
Requirements:
Fluent in spoken and written English
Scientific academic background (e.g. MSc in Engineering, Quality or similar)
Strong background in quality and stability
Relevant experience in stability documentation, medical devices and/or pharmaceuticals
Analytical mindset with structured problem-solving skills and a strong methodological approach
Knowledge of applicable regulatory and quality standards within the Medical Device industry
Willingness to travel (approximately 10 travel days per year)
Strong IT skills, especially Microsoft Office, Excel and PowerPoint
Team player with a collaborative mindset
Experience working in an international, cross-functional and cross-cultural environment