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Reference No. R2716901
Position Title: Manager, Batch Production Record Review
Duration: Fixed-Term – Contract End Date: June 30, 2025
Department: Batch Record Review
Location : Toronto, Ontario
Sanofi Vaccines
Sanofi’s global vaccines business unit partners with the public health, medical and scientific communities to improve access to life-protecting vaccines and increase vaccination coverage, while striving to develop new and improved vaccines to enhance health and well-being.
At Sanofi, we chase the miracles of science to improve people’s lives. We believe our cutting-edge science and manufacturing, fueled by data and digital technologies, have the potential to transform the practice of medicine, turning the impossible into possible for millions of people.
Position Summary:
The position is responsible for final review and approval of executed batch production records and associated documents per applicable procedures and guidelines.
The incumbent is accountable for quality and compliance of licensed products, in alignment with Sanofi Pasteur Quality Standards, Quality Systems, and current Good Manufacturing Practices. The incumbent is expected to work independently with a high level of autonomy and authority for decision making.
This position requires strong collaboration and communication with key responsible Partners in the Production units, and with other stakeholders across the organization, including within QO-OQ, OQ-SA, Validation Services, Product Quality, QC and Quality Systems.
Key Responsibilities:
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Ensuring timely review, follow-up on, and approval of executed batch records, and product batch related records.
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Ensure SAP activities linked to executed BPR review and approval are accurate and completed in a timely manner.
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Ensuring BPR process complies with GMP and regulatory requirements.
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Partner with production to improve “Right First Time” quality of approved BPRs, Batch Record review and approval cycle time; Implement continuous improvements.
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Quality Systems & Projects : Maintain training to perform the designated cGMP activities and meet Health Safety and Environment requirements. Maintain Quality Systems (as applicable) to be inspection ready at all times (e.g. deviation, CAPAs, change controls, audits and inspections). Review and approval of Master Batch Production Records (mBPRs) as required.
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Good familiarity/knowledge of biological manufacturing processes in the departments supported, current standards for sterilization techniques, aseptic techniques, clean room management and aseptic process control, relevant analytical methods, is fundamental to good performance on the job. Although the incumbent has no direct responsibility for materials/inventory or capital items, decisions based on documentation review may have far-reaching financial consequences.
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The ability to facilitate and prioritize the review of on-going activities in a timely fashion, often based on Master Production Schedule (MPS) timelines, requires: flexibility, constructive and/or innovative thinking in order to manage the process.
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Decisions are made based on established policies, procedures or standards. Errors in decision making are usually detected upon review and can be rectified with moderate effort or at limited cost. Decisions are based on multiple sources that will require further investigation or interpretation. Work consists primarily of duties requiring resolution through the choice of several learned policies and procedures.
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In addition, the incumbent will be responsible for their development, training and performance assessment of priorities and associated competencies agreed with management.
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The incumbent will operate in the context of multiple regulatory standards and requirements that are relevant to Sanofi Pasteur products and operations and must ensure that procedures comply with the appropriate regulations. For example: Canadian Food and Drug Act, US FDA 21 CFR, Pharmacopoeia (USP, EP, JP), MHRA, WHO/EC guidelines for GMP/GLP, TSE and Aseptic Processing.
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Tracking and Reporting of BPR performance metrics as required.
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The position will be working under the direction and guidance of Deputy Director.
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The position generally operates both in an office and manufacturing setting.
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The office environment requires intense concentration and visual examination, of documents.
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The position may require a particular vaccination for the areas of responsibility.
Key Requirements:
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Bachelor of Science or Engineering degree with relevant studies in field of Microbiology, Immunology or Pharmacology, Biochemistry or chemistry with 3+ years of relevant experience in Quality Operations from a Pharmaceutical or Biologics Manufacturing facility.
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Use of Technical/ Manager Expertise.
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Impact and Influence.
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Balanced Judgment/Risk Analysis.
Pursue Progress.
Discover Extraordinary
Better 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.
Watch our ALL IN video and check out our Diversity, Equity and Inclusion actions at sanofi.com!
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.
Thank you in advance for your interest.
Only those candidates selected for interviews will be contacted.
Follow Sanofi on Twitter: @SanofiCanada (https://twitter.com/SanofiCanada) and on LinkedIn: https://www.linkedin.com/company/sanofi
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At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
