B100 Bulk Compliance Professional

Job type: Full-Time
Accepting BioReady™: Yes
Category: General Management, Operations and Administration
Experience: 0-3 Years
Employer: Sanofi
Location: Toronto, ON
Posted: August 5, 2022
Closes: September 5, 2022

Job description:

Reference No.R2652213

Department: B100 – Projects and Process

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 B100 Bulk Compliance Professional will manage projects affecting the B100 Operations in relation to material readiness and onboarding for B100 project and compliance commitments and continuous improvement projects during routine operations. This role will also act as a diversified technical person who works within the Quality Systems to support B100 Operations in the context of change control lead/ super user during project and CAPA owner, lead investigator, as required.

Key Responsibilities:

Quality/ Project Management Support

• Provide project management support on compliance and material onboarding related activities specific to B100 Operations, with the aim to close gaps within the required timeframe and ensure material readiness for production activities.

• Work with external vendors, procurement, supplier quality, and MTECH to ensure materials are onboarded and ordered in time for project activities

• Update dashboards to communicate key performance and quality metrics to ensure operational readiness.

• Assist with building material masters for new raw materials and semi-finished goods for B100.

• During routine operation, provide project management support on compliance related activities and continuous improvement projects specific to B100 operations, with the aim to close gaps within the required timeframe and ensure uninterrupted production activities.

• B100 operations 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 B100 operations.

• Implements Corrective and Preventative Actions established as B100 commitments in response to Internal/ Global or Regulatory Audits.

• Identify opportunities for alignment across the B100 platform applying LEAN methodologies.

Change Control and CAPA Lead / Super User

• Initiate and manage change control requests affecting the B100 operations.

• Collaborate with assessors for evaluation of changes.

• Ensure timely closure of project and Phenix change controls.

• Support Lead Investigators and B100 operations in establishing change controls and /or CAPAs approved for execution in a very short timeframe to support closure of Deviations.

Technical Writing and Reviewer

• Update, review and approve GMP documents such as SOPs, SWIs, protocols, reports.

• Coach and oversee technical writing as needed.

• Prepare and present Metrics reports for B100 operations platform.

Lead Investigator Support

• Lead Investigator support to collect data and investigate for deviations affecting the B100 platform.

• 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.

Scope and dimensions

• Project management within B100 operations as required, in Toronto Canada.

• Diversified technical person who works within the Quality Systems to support B100 Platform in the context of change control lead/ super user, CAPA owner, lead investigator.

• Document Reviews:  Logbooks, SOPs/SWIs, mBPRs/eBRs.

Requirements

• Minimum Bachelor’s Degree in Sciences

• 2-4 years of practical job experience in a GmP environment

• Efficiently use company tools such as SAP, Phenix, QeDoc, etc. and the ability to adapt to new tools ( e-systems)

• Strong verbal and written communication skills.

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

#GD-SP#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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