Job detail for Quality Assurance Specialist

About the role

The Biologics Launch Unit Drug Product is the and launch unit of the Frankfurt BioCampus. Our Drug Product QA Operations Team is responsible for maintaining pharmaceutical quality standards and regulatory requirements for the aseptic manufacturing and visual inspection of biological medicinal products. With expertise and commitment, we actively support production operations in the implementation and execution of GxP-compliant processes, thereby contributing to the market launch and supply of biologics. 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 **

• Implementation, compliance, and maintenance of cGxP systems in the direct production environment of an aseptic manufacturing unit, which includes the areas of formulation/pooling, filling (RABS/isolator), and visual inspection

• Quality-related support of production with a high level of on-site presence, including in cleanroom class B

• Processing of deviations, change controls, CAPAs, pharmaceutical-technical complaints, and microbiological test results (environmental/personnel monitoring)

• QA review and approval of GxP documents, including batch documentation in the eBR (electronic Batch Record)

• Creation of training materials and conducting training sessions

• SME in audits and inspections

• Independent development of continuous process improvements in accordance with applicable GxP requirements

About you

• Education:

• Completed university degree in natural sciences or engineering, or state examination in pharmacy

• Experience:

• Several years of experience in Quality Assurance and/or Quality Control in the pharmaceutical industry

• Knowledge of quality management system processes and relevant pharmaceutical regulations

• Soft skills:

• Very good communication skills and ability to work in a team

• Motivation to learn new things

• Technical skills:

• Independent and results-oriented work according to applicable GxP requirements

• Analytical, solution-oriented thinking and a structured, proactive approach

• Languages:

• Very good written and spoken German and English skills

Why should you choose us?

• Discover the wonders of science with an innovative team to improve human health.

• 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.

• An attractive, market-oriented compensation and benefits package, including a company pension scheme, rewards your experience and contribution.

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 - €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.