Specialist, QA

Job title: Specialist, QA

Company: Sanofi


Job description: Reference No. R2799337Position Title: Specialist, QA – QC and E and MDepartment: QA Operations Support -TS, SC, DistDuration: Fixed term Contract End Date: November 27, 2026Location: Toronto, OntarioAbout the JobWe 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.This role is for a QA Specialist to support in the areas of QC, warehouse and E&M.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:Provides coaching and leadership to shopfloor staff, assuring that processes are executed effectively, compliantly and thereby enabling and promoting a Quality culture.Partners with production and operates with strong process knowledge and risk-based decision making, required on the shopfloor to support cGMP compliance.Responsible for timely and thorough deviation investigations, guiding the investigation team as required throughout the investigation process (problem definition, scope, investigation strategy, RCA, CAPAs) and ensures that batch decisions are compliance and science-based, and supported by strong data driven justification.Ensures timely review and approval of deviations, SOPs, CAPAs, ERs and other GxP documents such as Master Batch Production Records, operational log books, sterilization and depyrogenation records, work orders, worksheets, maintenance task lists, change control assessments and approvals, and protocols/ reports that are within the scope or delegated.Participates as QO Representative at various committees and boards such as: Sanofi Pasteur Change Control Board, Deviation Review Board, +QDCI, FFast, etc.Participates in self-inspections, periodic internal reviews/audits to ensure compliance procedures are followed, and participates in external audits/inspections Identifies and mitigates risks, and leads Shopfloor Quality improvement within the APT and more broadly as applicable.Ensures alignment to Global and new Regulatory requirements, participating in gap remediations, compliance and Site Projects as required.Support the OQ Deputy Director (as required) in the following (but not limited to) assessing and approving Process at Risk (PAR) forms, Provision batches in the eBAR for financial month end.About YouEducation and ExperienceBachelor of Science with 5 or more years of relevant experience in pharmaceutical or biological manufacturing.Minimum of 5 years knowledge of quality compliance in a GMP regulated environment.Experience in Engineering/maintenance is preferredExperience in QC is preferred.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 programsThis position is for a new vacant role that we are actively hiring for.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.#GD-SP ​
#LI-SP#LI-OnsitePursue progress, discover extraordinaryBetter 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 and check out our Diversity Equity and Inclusion actions at !North America Applicants OnlyThe salary range for this position is: $76,200.00 – $127,000.00All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the .La fourchette salariale pour ce poste est la suivante:$76,200.00 – $127,000.00Toute compensation sera déterminée en fonction de l’expérience démontrée. Les employés peuvent être admissibles à participer aux programmes d’avantages sociau de l’enterprise. Des informations supplémentaires sur les avantages sont disponibles via le .

Expected salary: $76200 – 127000 per year

Location: Toronto, ON

Job date: Tue, 20 May 2025 22:08:07 GMT

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