Quality Assurance Operations Specialist

About Sanofi:

We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.

About the job

Job Purpose

Maintain and manage the QA product shopfloor to ensure quality is built into the product. This guarantees the conformance of the final product with its predetermined specifications and compliance with GMP regulations, Sanofi industrial quality and compliance directives and guidelines, and local and national requirements.

Main Responsibilities:

• Participation in Investigations of Site Deviations:

• Conduct investigations assigned impacting product quality are investigated to evaluate the root cause, corrective actions, and preventive measures needed to prevent re-occurrence.

• Conduct LI-related investigation assigned to product quality to evaluate the root cause, corrective actions, and preventive measures needed to prevent re-occurrence.

• Shopfloor Activities:

• Review the batch record received in the assigned area of responsibility before release.

• Maintain compliance with local and Sanofi regulations in manufacturing areas.

• Implement the assigned CAPAs and Effectiveness Checks.

• Implement the assigned Change actions.

• Review and report the status of the quality stock at the QA level.

• Review the documentation assigned to the QualiPSO system.

• Attend & conduct the shopfloor meetings as assigned.

• Quality tours Conduct Quality tours & process observation within assigned areas.

• HSE Responsibilities:

• Commitment to the appropriate PPE use.

• Follow the approved HSE policy and requirements.

• Following the statutory legislation concerning Health, Safety, and environmental law.

• Others:

• Respect for the company’s values, code of ethics, and social charter.

• Show and apply the TRT & PTW principles.

• Respect for personal data protection charter.

About you

Education: Bachelors' degree in Pharmaceutical Sciences

Related Experience: Working in the pharmaceutical industry (3 – 5 years) in; QA, Shop Floor, IPC. QA, Compliance. Experience is preferable in a solid DF area.

Languages: Very Good written and spoken English

Key Skills:

• Good communication & presentation Skills

• MS Office User

• Shop floor activities.

• QA Documentation and compliance systems experience.

• Background knowledge in the pharmaceutical industry

• Decision making & problem solving.

• Risk management & Root cause analysis tools.

Key Competencies:

• Stretch to go beyond the level we have operated at up until now.

• Take rapid actions to meet the targeted and planned dates for each task.

• Act in the interest of our patients and customers.

• Put the organization's interests ahead of my own or our team's.

• Act for Change, strive for results, Cooperate Transversally, and Commit to Customer.

• Think Strategically, Lead Teams, Develop People, Make Decisions.

Take The Lead Values:

• Aim Higher: Focus on what matters, set high standards and move with urgency, learning from setbacks as we go to achieve higher performance.

• Act for patients: Never compromise on integrity, eliminate barriers, and partner with others to go faster and further for patients.

• Be Bold: Take thoughtful risks, seize opportunities and think beyond what’s possible to accelerate our science and drive compelling growth.

• Lead Together: Build trust and collaborate openly on our shared goals, celebrate collective wins and foster a sense of belonging.

Why choose us?

• Shape the future of medicine and vaccine delivery with cutting-edge technology, ensuring seamless launches and a resilient global supply.

• Power industry-leading performance by leveraging digital, data, and AI-driven innovation – at speed and scale.

• Transform lives worldwide by delivering life-changing treatments anywhere, anytime.

• Grow, thrive, and make an impact in a workplace that empowers you to bring your best self every day, with pride.

• Work with AI, robotics, and next-gen automation to redefine global manufacturing and supply.

• Be part of world-first initiatives like our Modulus factory, smart factories, and AI-driven supply chain solutions.

• Help deliver 30+ new product launches by 2030, ensuring patients get treatments faster than ever.

• Develop new skills, explore cross-functional roles, and work in an environment that values growth and discovery.

• Every year, we distribute over 4 billion units of medicines and vaccines, ensuring people worldwide receive the treatments they trust.

null