About the role
As a Qualified Person (Sachkundige Person according to §§14/15 AMG) at the Frankfurt BioCampus in the FBC QA Operations Fill & Finish department, you will be responsible for the GMP- and regulatory-compliant batch (partial) release of our products – and thus for the timely supply of life-extending, highly effective medicines to patients. In this central role within the pharmaceutical quality system, you will work on critical and strategic topics and projects, collaborating across a wide range of interfaces.
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 working to turn the impossible into the possible. 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.
Our team:
Our QP team is part of the Fill & Finish manufacturing area, which focuses on the production, filling, inspection, and packaging of sterile medicinal products distributed globally in high volumes. In the future, we will also expand our portfolio to include the import and further processing of products from third countries.
Key responsibilities:
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Batch release and batch certification of the respective medicinal product process stages for which you are responsible, in compliance with the underlying quality system according to legal requirements (AMG and AMWHV based on Annex 16, EU GMP guidelines, pharmacopoeia requirements, as well as other applicable international standards and guidelines) and ensuring GMP and regulatory compliance.
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Monitoring compliance with the quality system (Annex 16, Chap. 1.7), e.g., regarding the validation of manufacturing and testing procedures, approved work, manufacturing and testing instructions, evaluation of deviations and CAPA measures, change control procedures, and supplier qualification.
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Professional representation in audits and inspections by authorities and customers, and participation in communication with authorities.
About you
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Experience: Comprehensive knowledge of pharmaceutical law; sound knowledge of quality assurance principles and GMP guidelines; professional experience in the manufacturing and/or quality assurance of aseptic products (Annex 1) and pharmaceutical imports (Annex 21).
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Soft skills / Technical skills: Analytical, solution-oriented thinking; structured, independent, and meticulous way of working; strong communication and teamwork skills for collaborating with diverse stakeholders; a high level of integrity and sense of responsibility; proficient in MS Office applications and SAP.
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Education: License to practice as a pharmacist (university degree in Pharmacy); qualification as a Qualified Person according to §15 AMG paragraph (1) is required.
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Languages: German and English, fluent in both spoken and written.
Why should you choose us?
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Discover the wonders 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 work environments. For your commute, you will be supported by an individually usable monthly mobility budget.
#LI-GSA
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.
Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!
The salary range for this position is :€83.856,00 - €111.808
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.