QO OQ Shop Floor Manager
Genzyme
Toronto, ON
5d ago

Reference # : R2483767

Department : Q0 Compliance

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.

Job Accountabilities :

  • Support the Operational Quality Deputy Directors in ensuring timely review, follow-up on closure and approval of various documents, such as : master batch records, operational log books, SOPs, SWIs, deviations, protocols, reports, work orders, that are within the scope or delegated.
  • Ensure failure investigations / deviations are processed and that problem resolution occur prior to commitment date within Phenix.
  • Ensure that batch recommendations are based on sound science and supporting reports are of high quality.

  • Perform the role of QO Representative in coordinating, investigating and assessing Change Control Requests (CCR’s) and CAPAa as designated within this process.
  • This activity will require the incumbent to determine if a change request impacts product and processes.

  • In addition, the incumbent might have to be a QO Representative at various internal and external committees and board related to the management of the organization, such as : Sanofi Pasteur Change Control Board, Material Review Board, +QDCI (mandatory), FFast, etc.
  • Ensure through shop floor presence and knowledge transfer, that there is in-depth GMP understanding as it pertains to specific operations and that issues are identified locally and dealt with through close collaborative contact with the various departments.
  • In conjunction with the QO Quality System Internal Auditor and Vendor Auditor, perform audits and support functions performing GMP activities to ensure compliance with cGMP standards, site and corporate policies.
  • Make assessment decisions and authorization for processing / reworking, manufacturing at risk.
  • Project team participation.
  • Education and Experience :

  • Bachelor of Science degree specializing in Microbiology, Biochemistry, Immunology or Pharmacology with 5+ years of relevant experience in Quality Operations from a Pharmaceutical or Biologics Manufacturing facility.
  • Master of Science degree in Microbiology, Biochemistry or Immunology with 3+ years of relevant experience in Quality Operations from a Pharmaceutical or Biologics Manufacturing facility.
  • 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.

    LI-SP

    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.

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