Job detail for Quality Assurance Specialist

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About the role

As a QA Specialist within our Quality Fill & Finish team – APU Packaging, you will be responsible for the quality assurance of sterile pharmaceutical packaging at the FBC Campus. 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 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.

**Key **

• Support all quality activities in the corresponding packaging production unit
• Processing of deviations and change controls: definition and tracking of resulting follow-up measures (CAPAs) as well as root cause analysis and evaluation of semi-finished product batches
• Execution/support of (re-)validation and qualification activities as well as the creation of the associated documents
• Support for the introduction of new products
• On-site support for packaging lines in the production unit
• Creation/revision of annual Product Quality Reviews, trend analyses, and SOPs within the area of responsibility
• Conceptualizing and participating in process validations or in the definition of quality-relevant parameters and measuring points
• Planning, defining, and implementing validation measures
• Processing of issues and projects within the production unit, taking cGMP into account in close cooperation with other functions
• Review and approval of master documents of the APU, including manufacturing protocols
• Support of the QA-BRR in the review of batch documentation, batch evaluation, and the implementation of batch release
• Review of internal and regulatory requirements
• Conducting gap and risk analyses
• Preparation for and support during inspections of the production units by authorities, customers, and internal departments
• Exchange of experience with other units at the Insulin Campus Frankfurt

About you

Education

• Degree or Master's degree in Pharmacy or Natural Sciences

Experience

• 2-3 years of practical experience in the pharmaceutical industry in a GMP environment (e.g., quality assurance, quality control, production) with experience in establishing and maintaining GMP and regulatory compliance

Soft skills

• Sociability and organizational skills
• Team spirit
• Strong communication skills and a distinct drive for advantageous solutions for the customer
• Ability to work in national and international teams
• Open to change, improvements, and innovation

Technical skills:

• Knowledge of national and international current GMPs (incl. EU, FDA)
• Independent, self-responsible work according to GMP requirements
• Making decisions and taking responsibility
• Commitment to quality
• Flexibility, high resilience, and assertiveness

Languages

• Very good language skills in German and good language skills in English

Why should you choose us?

• Discover the miracles of science with an innovative team to improve people's health.
• Find diverse opportunities in an international working environment to develop your talent professionally and personally and to continuously advance your career through internal changes 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.
• We take care of you and your family with a wide range of health and social benefits such as high-quality healthcare, many prevention programs, free vaccinations, and coverage for long-term illness. Outstanding is our 14-week paid family leave after the birth of a child for both parents, as well as other diverse support for childcare and the care of relatives.
• To optimize your work-life balance, you benefit from flexible working time models and long-term accounts. Benefit from our Hybrid Work Policy, use our fitness centers, or choose the option to participate in the bike leasing program. One day per year is available to you for voluntary social projects as part of our "We Volunteer" program.

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 :€80 724,00 - €107 620

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.