Reference No. R2785662

Position Title: Quality Assurance Specialist

Department: QA Operations Support 2 - TS, SC, Dist

Duration: 6 months

Location: Toronto, Ontario

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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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 (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) !

Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi (https://youtu.be/96EwNjb1TLo)

As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live.

All in for Diversity, Equity and Inclusion at Sanofi - YouTube (http://www.youtube.com/watch?v=SkpDBZ-CJKw&t=2s)