Overview
Batch review specialist Jobs in Toronto, Canada at Sanofi
R2860560 Batch review specialist
Location: Toronto, ON
Duration: 1 year
About the job
Join a global network that powers how Sanofi delivers — seamlessly, purposefully, and Manufacturing & Supply, you’ll help reimagine how life‑changing treatments reach people everywhere, faster.
Our Team / Overview
The Quality Assurance team serves as a critical guardian of patient safety and product excellence through rigorous GMP record review and batch release activities, while fostering a culture of quality ownership and continuous improvement across operations. Through systematic oversight and shopfloor expertise, we proactively identify and mitigate quality risks, maintain robust quality systems, and ensure full regulatory compliance. Our collaborative partnerships across all functions embed quality principles into every aspect of operations, enabling the timely delivery of high‑quality products to patients while upholding the highest standards of operational excellence.
About
Sanofi
We’re an R&D‑driven, AI‑powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system– and innovative pipeline– enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.
Main Responsibilities
- Ensuring that activities in his/her scope are conducted in compliance with applicable regulatory requirements
- Reviewing batch records and associated documentation
- Ensuring all conditional batch release activities comply with Good Manufacturing Practices (GMP)
- Fostering a culture of quality and continuous improvement across the organization
- Participating in internal and external audits and regulatory inspections providing support and documentation
Key Roles (D, A, I)
- Prioritize quality and compliance objectives (D)
- Approve a batch record if it is correctly completed and meets the quality requirement for one lot (D)
- Check whether all practices are done according to quality requirement; if not, assure that a deviation is opened and reported in the batch record (D)
- Review documentation for batch disposition (A)
- Advise on initiatives to promote a quality-focused culture (A)
- Advise on how to present a topic and answer specific questions (A)
Additional Accountabilities
- Ensure timely review, follow‑up and approval of executed batch records and as
- Ensure SAP activities linked to executed BPRs are complete and accurate.
- Escalate to Management on quality events detected; propose resolutions in partnership with Production and QA specialists.
- Partner with Production to ensure cycle times are met and implement continuous improvements as required.
- Responsible for the execution and timely completion of Quality System commitments (deviations, CAPAs, change controls, audit and regulatory) as applicable.
- Lead/execute projects that improve safety, quality, delivery, cost, involvement and strategic priorities.
- Any other duties that may arise as required.
About You
- Bachelor of Science or Engineering degree with 3+ years of relevant experience in Quality Operations from a Pharmaceutical or Biologics Manufacturing facility.
- Use of Technical/ Manager Expertise.
- Impact and Influence.
- Balanced Judgment/Risk Analysis.
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.
EEO statement
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.
Benefits
All 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 here.
Benefits (French)
Toute compensation sera déterminée en fonction de l’expérience démontrée. 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.
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Title: Batch review specialist
Company: Sanofi
Location: Toronto, Canada
Category:
