About the Role
As a QA Batch Review Specialist (all genders) within our BRR QA Fill & Finish Team, you will actively participate in the release of batches by reviewing batch records of sterile products and associated documentation, thereby ensuring product and patient safety. Ready for your start?
About Sanofi:
We are a research-driven biopharmaceutical 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.
About the Team:
Our Fill & Finish department is responsible for the aseptic filling and finishing of pharmaceutical products under the strictest GMP conditions. In the Batch Record Review area, we ensure complete documentation and quality review of every manufacturing batch record. Our team reviews all process data, deviations, and in-process controls to ensure product quality and patient safety. We work closely with Production, Quality Control, and Regulatory Affairs and drive continuous improvement of our review processes.
Key Responsibilities:
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Review batch records (in German and English) of sterile products and associated documentation for completeness and accuracy in the Fill and Finish department of the Frankfurt BioCampus
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Ensure that documentation is performed in accordance with cGMP and that all process requirements according to the manufacturing protocol and corresponding SOPs are met.
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Assist in the preparation of QP release of batches
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Filing of documents/archiving
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Creation and processing of documents in the GMP environment
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Support for qualification/validation activities
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Participation in the introduction of new products
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Preparation and support for audits and inspections
About You
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Education: Training in pharmaceutical-chemical or natural sciences
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Experience: Several years of experience in the pharmaceutical industry, particularly in the GMP environment (e.g., quality assurance, quality control, production, ideally cleanroom); experience in handling and creating production-relevant documents in English; experience with manufacturing documentation is advantageous; sound knowledge and confident use of CMS (e.g., QualiPSO) and SAP
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Social Skills / Technical Abilities: Precise and focused working style and organizational skills; sociability and teamwork; ability to work proactively in cross-functional/interdisciplinary teams (Supply Chain/Manufacturing Management/QA/QC/QP); good knowledge of national and international cGMPs (including EU, FDA); personal commitment to quality in work, ability to set goals and standards; good understanding of pharmaceutical production and sterilization processes; analytical thinking and care in document review; high resilience and the ability to prioritize tasks even in stressful situations
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Languages: Excellent German and good 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 to continuously advance your career through internal moves 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 :€0,00 - €0
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.