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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 REQUIREMENTS:

• 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.
• Use of Technical/ Manager Expertise.
• Impact and Influence.
• Balanced Judgment/Risk Analysis.

RESPONSIBILITIES

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

KEY RESPONSIBILITIES:

• Ensuring timely review, follow-up on, and approval of executed batch records, and product batch related records.
• Ensure SAP activities linked to executed BPR review and approval are accurate and completed in a timely manner.
• Ensuring BPR process complies with GMP and regulatory requirements.
• Partner with production to improve “Right First Time” quality of approved BPRs, Batch Record review and approval cycle time; Implement continuous improvements.
• 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.
• 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.
• 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.
• 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.
• In addition, the incumbent will be responsible for their development, training and performance assessment of priorities and associated competencies agreed with management.
• 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.
• Tracking and Reporting of BPR performance metrics as required.
• The position will be working under the direction and guidance of Deputy Director.
• The position generally operates both in an office and manufacturing setting.
• The office environment requires intense concentration and visual examination, of documents.
• The position may require a particular vaccination for the areas of responsibility.