Job detail for Quality Assurance Specialist
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About the Role
As a Quality Assurance Specialist within our Drug Substance QA Team of the Biologics Launch Unit, you will support the compliance with pharmaceutical quality standards and regulatory requirements for the and market launch of biological active substances at the Frankfurt BioCampus – working closely with two state-of-the-art production facilities (CAPI & MLP). Ready for your start?
About Sanofi:
We are a research-driven company that applies AI and is committed to improving people's lives and growing responsibly. Our deep understanding of the immune system – and our innovative pipeline – enable us to develop medicines and vaccines that treat and protect millions of people worldwide. Together, we explore the wonders of science to improve people's lives.
Key :
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Plan and further develop the chemical-biological and pharmaceutical quality of manufactured biological active substances, taking into account the current state of science and technology as well as compliance with current regulations (laws, guidelines, etc.)
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Implement inspection-compliant quality concepts by contributing expert knowledge in operations, during inspections and quality audits, and ensuring compliance with regulatory requirements, particularly GMP-compliant documentation
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Review and approve manufacturing instructions, facility-specific SOPs, validation/qualification plans and reports, and assess deviations, CAPAs, and change controls
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Design and participate in process transfers, process and cleaning validations, qualifications, definition of quality-relevant process parameters and measurement points in manufacturing, as well as the required quality scope of equipment used
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Implementation of continuous improvement processes with regard to data integrity, risk management, and compliance
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Standardization, simplification, and harmonization of workflows and processes
About You
Experience:
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Several years of experience in Quality Assurance and/or Quality Control in the pharmaceutical industry
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Knowledge of quality assurance system processes and relevant pharmaceutical regulations
Social Skills / Technical Abilities:
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Independent and results-oriented work according to applicable GxP requirements
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Excellent communication skills and teamwork ability
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Analytical, solution-oriented thinking and structured, proactive approach
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Motivation to learn new things
Education:
- Completed degree in natural sciences or engineering, or state examination in pharmacy
Languages:
- Excellent German and English language skills, both written and spoken
Why Should You Choose Us?
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Discover the wonders of science with an innovative team to improve people's health.
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Find diverse opportunities in an international work environment to develop your talent professionally and personally, and continuously advance your career through internal transfers and role expansions. Individual and structured onboarding is a given and begins before your first day.
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An attractive, market-aligned compensation and benefits package including occupational pension provision honors 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. An individually usable monthly mobility budget supports your commute to work.
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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 :€79 104,00 - €118 656,00
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.