Specialist, Quality Assurance

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This range is provided by Sanofi. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

CA $76,200.00/yr - CA$/yr

Reference No
: R2819973

Position Title: Specialist, Quality Assurance

Department: Quality DCV & GEM

Location: Toronto, ON

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.

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?

• Coordinates with QA Coordination Call Center to obtain essential information required to document technical complaints
• Provides support to QA Coordination Call Center to meet needs of the complainant
• Identifies and confirms inquiries as product technical complaints
• Evaluates complaints for severity and risk to public safety
• Notifies interested departments (e.g., Country Quality Head, manufacturing site QA) upon receipt of critical complaints
• Monitors and tracks sample receipt from complaints
• Ensures complaints are reviewed and processed within a timely fashion
• Prioritizes complaints for data entry and processing into the global database
• Utilizes the customer service database to oversee complaint identification and processing
• Interacts with both internal and external manufacturing sites regarding technical complaints and their associated investigations
• Performs QC Checks
• Understands Health Canada complaint regulations for drug products and medical devices
• Performs file review and administrative closure for individual complaints
• Produces trending reports
• Monitors open complaint activity for each manufacturing site
• Interacts with Customer Service, Medical Information, Pharmacovigilance and other company departments/associates regarding the identification and evaluation of technical complaints
• Identifies and reports adverse events within one business day to Pharmacovigilance
• Provides complaint support to other company departments including Customer Service, Medical Information, Pharmacovigilance, Sales Associates, Regulatory, Commercial Operations, Legal, and Risk Management
• Participates on ad-hoc teams regarding product-specific complaint issues
• Supports during regulatory, third party, and internal audits
• Understands product specific information regarding common product complaints
• Understands department process flows and complaint databases
• Coordinates feedback to customers regarding complaint investigations via QA Coordination Call Center
• Other QA duties, as assigned

• B.Sc. in Chemistry, Biology or related sciences
• 5 years of related experience within the pharmaceutical industry
• Knowledge of cGMPs and Health Canada regulations regarding drugs, medical devices, combination products, biologics and natural health products
• Strong understanding of Good Documentation Practices
• Must be able to understand and utilize complaint database software and reporting tools
• SAP, MS Office, Adobe Suite
• Bilingual French strongly preferred
• Occasional travel:
  Position is based out of the Toronto office
• Persons 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.

• Problem solving mindset with strong organizational, analytical and detail-oriented skills
• Customer service, project and time management skills
• Interpersonal skills;…