Manager Batch Production Records

at  Sanofi

OVERVIEW

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POSITION SUMMARY:

Sanofi Pasteur Limited is looking for an innovative and results driven individual to join our Document Management team as mBPR (master Batch Production Records) Manager. Supporting a site mBPR initiative and reporting to Product Quality - Document Management, you will have the following responsibilities:

KEY REQUIREMENTS:

• A minimum of a B.Sc degree in Life Science-related field (e.g. Biology, Biochemistry, Biotechnology, Pharmacology, Chemical Engineering and Health Science).
• 4 – 6 years experience and understanding of manufacturing/testing environments in the pharmaceutical Biotech Industry.
• Knowledge and competencies in project management principles.
• The ability to manage/handle multiple projects and respect timelines.
• Work as a team, creativity, work with time constraints for completion of deliverables as per schedule and be able to quickly respond to changing priorities.

RESPONSIBILITIES

Reference No. R2698787
Position Title: Manager Batch Production Records
Duration: Fixed-Term - Contract End Date: December 20, 2024
Department: Document Management
Location: Toronto, Ontario

KEY RESPONSIBILITIES:

• Create and update mBPRs (design/re-design mBPRs in a consistent manner, ensure the technical components of the mBPRs conform to manufacturing procedures, master specifications, and GxP requirements. The results should be mBPRs that are efficient, effective and compliant).
• Optimize and standardize mBPRs (seek opportunities to improve our recording of manufacturing data and apply these improvements to new mBPRs or during the maintenance/updating of existing ones, create and maintain the database of standard objects).
• Support continuous improvement initiatives within manufacturing (support new initiatives and/or manufacturing facilities by providing guidance in data recording requirements, drive standardization of manufacturing methods across similar processes, coordinate and facilitate discussions in the development of mBPRs with all stake holders).
• Maintain the mBPR and associated supplement/form printing packages.
• Write and maintain policy documents.
• Participate in validation activities for BPR management systems upgrades, as applicable.