Sanofi Group B90 Compliance Professsional in Toronto, Ontario

Bulk compliance Professional

Location: Sanofi Pasteur Limited / North York, Ontario

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.

Mission

This role will manage projects affecting the Bulk platforms in relation to compliance commitments and continuous improvement projects. This role will also act as a diversified technical person who works within the Quality Systems to support Bulk Manufacturing in the context of change control lead/ super user, CAPA owner, lead investigator.

Key accountabilities

  1. Quality/ Project Management Support 50%

• Provide project management support on compliance related activities and continuous improvement projects specific to Bulk platforms or site-wide, with the aim to close gaps within the required timeframe and ensure uninterrupted production activities.

• Bulk representative for Site Wide Initiatives/ Continuous Improvement projects related to Quality Systems, Processes and Procedures.

• Perform and/or participate in GQD gap analysis for the Bulk Manufacturing Department.

• Implements Corrective and Preventative Actions established as Bulk wide commitments in response to Internal/ Global or Regulatory Audits.

• Identify opportunities for alignment across the Bulk platforms or within a specific area, applying LEAN methodologies.

  1. Change Control Lead / Super User 15%

• Initiate and manage change control requests affecting the Bulk Manufacturing department.

• Collaborate with assessors for evaluation of changes.

• Ensure timely closure of change controls.

• Support Lead Investigators and Bulk Manufacturing Platforms in establishing change controls approved for execution in a very short timeframe to support closure of Quality Notifications.

  1. Technical Writing 10%

• Prepare and update GMP documents such as SOPs, SWIs, protocols, reports.

• Coach and oversee technical writing TPW as needed.

• Prepare Metrics reports for Bulk Manufacturing.

  1. Lead Investigator as assigned 25%

• Lead Investigator to collect data, investigate and draft report for Quality Notifications affecting the Bulk platforms.

• Collaborate transversally (QO, TS, MTECH, SME, QC etc.) to support the investigation.

• In collaboration with platform management and other stakeholders, identify and develop appropriate CAPA to address the root cause.

Education/Experience:

4-year Bachelor’s degree in Science

5 years on the job experience

Hours of Work:

Monday to Friday 8:00a.m.-4:00p.m.

Sanofi Pasteur Canada embraces diversity in the workplace and is committed to achieving employment equity. 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 applications from women, members of visible minorities, Aboriginal peoples and persons with disabilities.

Thank you in advance for your interest.

Only those candidates selected for interviews will be contacted.

We are an equal opportunity employer.

Applications received after the official close date will be reviewed on an individual basis.

Once selected for interview, internal applicants are required to notify their manager.

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Sanofi is a global healthcare leader focused on patients' needs, engaged in the research, development, manufacturing and marketing of therapeutic solutions focused on patients’ needs. Sanofi has core strengths in diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets and Sanofi Genzyme.

At Sanofi, our ambition is to be an integrated global healthcare company, focused on patients’ needs. Much more than just a leading pharmaceutical company, Sanofi is committed to transforming scientific innovations into solutions and services that protect health, enhance life, and respond to the needs of the 7 billion people in the world. We trust our ambition to guide and inspire us as we work to create a future with optimal health and wellness for everyone.

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.

Sanofi, Empowering Life