Quality and Stability Specialist
Let’s be successful together!
Our multinational Partner is looking for an experienced colleague for the position below:
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.
The registration No. of Hire-One Ltds. is this: 3376/2008.
Scientific academic background (e.g. MSc in Engineering, Quality or similar);
Advanced English language skills;
Analytical mindset with structured problem-solving skills and a strong methodological approach;
Willingness to travel (approximately 10 travel days per year);
Strong IT skills, especially Microsoft Office, Excel and PowerPoint;
Team player with a collaborative mindset.
A respectful, supportive work environment with innovative leaders;
A comfortable, modern workplace;
Work-lifa balance (flexible working hours, 4 days/month home-office);
Continuous professional development and training opportunities.
Relevant experience in quality or stability documentation, medical devices and/or pharmaceuticals;
Knowledge of applicable regulatory and quality standards within the Medical Device industry;
Experience working in an international, cross-functional and cross-cultural environment.