Quality Assurance Specialist QA Operations Devices
Summary
Ensures medical devices meet regulatory and quality standards through testing and documentation in a healthcare company.
About the position
As a Quality Assurance Specialist QA Operations Devices within our QA Operation Unit Devices APU AI team, you will support production and be responsible for quality assurance for Medical Devices. The QA Operation Unit Devices APU AI department is part of the APU Autoinjectors. The APU Autoinjectors is responsible for the manufacturing of Medical Devices (combination products) for use against conditions including atopic dermatitis, asthma, and rheumatoid arthritis. We are a rapidly growing area within FBC with an interface to Specialty Care, which on one hand ensures market supply with products such as Dupixent, but also serves as a launch site for new products. To support our team, we are looking for a QA Specialist to support production (m/f/d). Ready to get started?
About Sanofi:
We are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve people’s lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by turning impossible into the possible for patients. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions.
Key responsibilities:
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QA support for the production of autoinjectors in the APU AI (ensuring GMP compliance, deviation and change management, assessment of technical reports) according to internal prioritization to ensure market supply
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Assessment of manufacturing-related PTCs (Pharmaceutical Technical Complaints)
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Participation in the creation of Master Manufacturing Reports and SOPs
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Creation of documents for validations, Business Quality Representative for production facilities
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Participation in audits and inspections as an expert
About you
Experience:
- Knowledge in the field of quality assurance or manufacturing of combination products
Social skills / Technical skills:
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Experience in a GMP environment
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Structured, independent way of working
Education:
- Completed degree in natural sciences
Languages:
- Fluent in German and English, both written and spoken
Why should you choose us?
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Discover the miracles of science with an innovative team to improve human health.
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Find diverse opportunities in an international work environment to develop your talent professionally and personally, and to continuously advance your career through internal moves and role expansions. Individual and structured onboarding is a matter of course and begins even before your first day.
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An attractive, market-oriented compensation and benefits package, including company pension schemes, rewards your experience and contribution.
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Start your career at an attractive location in the heart of Germany and experience our modern working environments. For your commute, you will be supported by an individually usable monthly mobility budget.
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#PursueProgress
Pursue progress, discover extraordinary
Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.
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The salary range for this position is :€79 104,00 - €105 472
Final compensation will be determined based on demonstrated experience, skills, location, and other relevant factors. Employees may be eligible to participate in Company employee benefit programs.