Reference No. R2656127
Position Title : Manager, Batch Production Record Review
Department : Batch Record Review
Location : Sanofi Pasteur Limited, Toronto
Sanofi Pasteur : The world’s leading vaccine company
Sanofi Pasteur, the vaccines division of Sanofi, is the largest company in the world devoted entirely to human vaccines.
Our driving goal is to protect people from infectious diseases by creating safe and effective vaccines. Our company distributes more than 1 billion doses of vaccine each year, making it possible to vaccinate more than 500 million people across the globe.
Sanofi Pasteur offers the broadest range of vaccines in the world, providing protection against 20 bacterial and viral diseases.
Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health.
We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.
Position Summary :
The position is responsible for final review and approval of executed batch production records and associated documents per applicable procedures and guidelines.
This person’s role is vital as independent quality review of critical manufacturing data to assure the consistent quality of each manufactured lot before it is marketed.
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.
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 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.
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.
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.
Sanofi, Empowering Life
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.