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About the Role
The Quality Assurance Specialist provides quality oversight and guidance to the designated Autonomous Production team (APT) or area of responsibility, on all aspects of Shop floor / operational activities. The incumbent is accountable for quality and compliance of licensed products, in alignment with Sanofi Quality Standards, Quality Systems, and current Good Manufacturing Practices. This position requires strong collaboration and communication with key responsible Partners in the APT, and with other stakeholders across the organization.
Responsibilities
- Provides coaching and leadership to shop floor staff, assuring that processes are executed effectively and compliantly.
- Partners with production and operates with strong process knowledge and risk-based decision making to support cGMP compliance.
- Responsible for timely and thorough deviation investigations, guiding the investigation team and ensuring batch decisions are compliance and science-based.
- Ensures timely review and approval of deviations, SOPs, CAPAs, ERs and other GxP documents.
- Participates as QA Representative at various committees and boards.
- Participates in self-inspections, periodic internal reviews/audits to ensure compliance procedures are followed.
- Participates in external audits/inspections.
- Identifies and mitigates risks, and leads Shop floor Quality improvement within the APT.
- Ensures alignment to Global and new Regulatory requirements, participating in gap remediation's, compliance and Site Projects.
Requirements
- Bachelor of Science with 3 or more years of relevant experience in pharmaceutical or biological manufacturing environment.
- Strong leadership and management capability.
- Excellent knowledge of cGMPs, compliance trends and vast amount of experience with inspections/audits.
- Excellent problem solving (root cause analysis) and investigation skills.
- Strong influencer and communicator.
- Solid experience with continuous improvement methodologies and risk-based approaches.
Skills
- cGMPs
- Risk-based decision making
- Root cause analysis
- Continuous improvement methodologies
Location
- Toronto, ON
Work Type
- Fixed Term Contract
- Onsite
Experience Level
- 3 or more years of relevant experience
Education Level
- Bachelor of Science
Salary/Compensations
- 76,200.00 - 110,100.00
Benefits
- High-quality healthcare
- Prevention and wellness programs
About the Company
- Sanofi is an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth.
- Sanofi Vaccine is the world’s leading vaccine company, devoted entirely to human vaccines.
- Sanofi distributes more than 1 billion doses of vaccine each year.
- Sanofi Pasteur offers the broadest range of vaccines in the world.
- Sanofi is dedicated to supporting people through their health challenges.
- Sanofi is transforming scientific innovation into healthcare solutions around the globe with more than 100,000 people in 100 countries.
Equal Opportunity
- Sanofi is an equal opportunity employer committed to diversity and inclusion.
- We welcome and encourage applications from all qualified applicants.
- Accommodations for persons with disabilities required during the recruitment process are available upon request.
- Sanofi provides equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.