Quality Assurance Specialist

Reference No. R2785662

About the Job

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.

As a member of the Quality Assurance Operations team, this role will provide compliance support to Deputy Directors for licensed product, support teams in managing their day-to-day operations in compliance with Sanofi Pasteur quality systems requirements and Good Manufacturing Practices.

The incumbent will provide Operational Quality support for designated departments of Industrial Operations (such as Formulations Filling & Packaging, Media Services, , Materials Management/Logistics, Sterility Assurance).

The incumbent is expected to work independently with a level of autonomy and authority for decision making as a delegate to the QA Operations Lead as necessary to drive process improvements, ensure ongoing compliance to requirements in the dossier, current GMPs, and also achieve process efficiencies.

We are an innovative global healthcare company that helps the world stay ahead of infectious diseases by delivering more than 500 million vaccine doses a year. Across different countries, our talented teams are exploring new technologies to protect people and promote healthy communities. We chase the miracles of science every single day, pursuing progress to make a real impact on millions of patients around the world.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Main Responsibilities

• Support the QA Operational Lead in ensuring timely review, follow-up on, closure and approval of various documents, such as: master and executed batch records, operational logbooks, sterilization records, SOP, SWI, deviation, protocols, reports, work orders, worksheets, change controls, that are within the scope or delegated.

• Ensure failure investigations/deviations are processed and that problem resolution occurs in a timely manner. Ensure that batch recommendations are based on sound science and supporting reports are of high quality.

• Perform the role of QA representative in coordinating, investigating and assessing Change Control Requests (CCR’s) and CAPA, as designated within this process. This activity will require the incumbent to determine if a change request impacts product and processes.

• In addition, the incumbent might have to be a Quality Representative at various internal projects

• Ensure through shop floor presence and knowledge transfer, that there is in-depth GMP understanding as it pertains to specific operations and that issues are identified locally and dealt with through close contact with the various departments.

• Develop tools for performance monitoring and provide feedback to the departments supported both formally (departmental presentations) and informally (shop floor review) and obtain agreement on corrective actions as required.

• Perform data gathering and analysis of non-conformances to support annual product review.

• Project team and Continues Improvement participation

About You

Education and Experience

• Bachelor of Science with 2 or more years of relevant experience in pharmaceutical or biological manufacturing.

Why Choose Us?

• Bring the miracles of science to life alongside a supportive, future-focused team.

• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.

• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.

• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs

This position is for a new vacant role that is now open for applications.

Sanofi is an equal opportunity employer committed to diversity and inclusion. Our goal is to attract, develop and retain highly talented employees from diverse backgrounds, allowing us to benefit from a wide variety of experiences and perspectives. We welcome and encourage applications from all qualified applicants.  Accommodations for persons with disabilities required during the recruitment process are available upon request.

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