Get AI-powered advice on this job and more exclusive features.Sanofi provided pay rangeThis range is provided by Sanofi. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.Base pay rangeCA$76,200.00/yr - CA$110,066.66/yrReference No: R Position Title: Specialist, Quality AssuranceDepartment: Quality DCV & GEMLocation: Toronto, ONAbout 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.Contribute to establishing and maintaining high quality and compliance status of all products handled by Sanofi Canada to meet all Canadian cGMP regulations, as well as corporate requirements.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 ResponsibilitiesCoordinates with QA Coordination Call Center to obtain essential information required to document technical complaintsProvides support to QA Coordination Call Center to meet needs of the complainantIdentifies and confirms inquiries as product technical complaintsEvaluates complaints for severity and risk to public safetyNotifies interested departments (e.G., Country Quality Head, manufacturing site QA) upon receipt of critical complaintsMonitors and tracks sample receipt from complaintsEnsures complaints are reviewed and processed within a timely fashionPrioritizes complaints for data entry and processing into the global databaseUtilizes the customer service database to oversee complaint identification and processingInteracts with both internal and external manufacturing sites regarding technical complaints and their associated investigationsPerforms QC ChecksUnderstands Health Canada complaint regulations for drug products and medical devicesPerforms file review and administrative closure for individual complaintsProduces trending reportsMonitors open complaint activity for each manufacturing siteInteracts with Customer Service, Medical Information, Pharmacovigilance and other company departments/associates regarding the identification and evaluation of technical complaintsIdentifies and reports adverse events within one business day to PharmacovigilanceProvides complaint support to other company departments including Customer Service, Medical Information, Pharmacovigilance, Sales Associates, Regulatory, Commercial Operations, Legal, and Risk ManagementParticipates on ad-hoc teams regarding product-specific complaint issuesSupports during regulatory, third party, and internal auditsUnderstands product specific information regarding common product complaintsUnderstands department process flows and complaint databasesCoordinates feedback to customers regarding complaint investigations via QA Coordination Call CenterOther QA duties, as assignedRequirementsB.Sc. in Chemistry, Biology or related sciences5 years of related experience within the pharmaceutical industryKnowledge of cGMPs and Health Canada regulations regarding drugs, medical devices, combination products, biologics and natural health productsStrong understanding of Good Documentation PracticesMust be able to understand and utilize complaint database software and reporting toolsSAP, MS Office, Adobe SuiteBilingual French strongly preferredOccasional travel: Position is based out of the Toronto officePersons applying for positions in QA must provide evidence of qualifications, as outlined in current Canadian Good Manufacturing Practices (GMP) Guidelines for review and assessment as a condition of any offers of employment.Preferred SkillsProblem solving mindset with strong organizational,



analytical and detail-oriented skillsCustomer service, project and time management skillsInterpersonal skills; proactive, personable, flexible, team-orientedAbility to multitask in a stressful and changing environmentStrong verbal and written communication skillsPersons applying for positions in QA must provide evidence of qualifications, as outlined in current Canadian GMP Guidelines.Why Choose Us?Bring the miracles of science to life alongside a supportive, future-focused teamGrow your talent and career through promotions or lateral moves, at home or internationallyEnjoy a rewards package that recognizes your contribution and amplifies your impactAccess health and wellbeing advantages including high-quality healthcare, prevention and wellness programsThis position is for a current 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.Les employés peuvent être admissibles à participer aux programmes d'avantages sociaux de l'entreprise. Des informations supplémentaires sur les avantages sociaux peuvent être trouvées ici.Join Sanofi and pursue progress and discoveries. At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, protected veteran status or other characteristics protected by law.#J-18808-Ljbffr

📌 Specialist, Quality Assurance (Toronto)
🏢 Sanofi
📍 Toronto