Manager Batch Production Record Review

Job description

Manager, Batch Production Record Review

Reference #: R2500522

Department: Quality Operations

Location: Toronto, Ontario

About Sanofi Pasteur

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 Manager, Batch Production Record Review is responsible for final review and approval of executed batch production records and associated documents per applicable procedures and guidelines. This is vital as independent quality review of critical manufacturing data to assure the consistent quality of each manufactured lot before it is marketed.

Key Accountabilities:

Responsible for final review and approval of executed batch records:

·  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.

Education and Experience:

·  Bachelor of Science or Engineering degree in related field (eg Microbiology, Immunology or Pharmacology, Biochemistry or Chemistry)
·  Min 3 (three) years of relevant experience in Quality Operations (Manufacturing) from a Pharmaceutical or Biologics Manufacturing facility
·  Use of Technical/ Manager Expertise (no direct reports for currently for this role)
·  Ability to communicate and work with a very broad spectrum of professional and technical staff to effectively manage in an efficient and practical manner
·  Flexibility to plan and work with rapidly changing business needs and ability to troubleshoot and resolve as a subject matter expert

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

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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.