Quality Sterility Assurance and Microbiology Specialist

Sanofi•Toronto, ON

1d•CA$76,200 - CA$110,100•Onsite

About The Position

Join a global network that powers how Sanofi delivers — seamlessly, purposefully, and at scale. In Manufacturing & Supply, you’ll help reimagine how life-changing treatments reach people everywhere, faster. Sanofi is an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.

Requirements

Three‑year diploma or bachelor’s degree with 1-2 years of experience.
Experience in sterility assurance and microbiological control within a pharmaceutical or biotechnology environment is highly preferred.
Ability to meticulously review and analyze documentation, processes, and products to ensure compliance with Sanofi GOP / Quality standards
In-depth knowledge of regulatory requirements and Good Manufacturing Practices (GMP) relevant to sterility assurance and microbiological control
Communication skills to communicate with a large number of functions (from shopfloor to management) and to present complex subjects
Ability to organize and lead routine investigations with a multi-disciplinary team

Responsibilities

Sterility Assurance and Microbiology Control PCU Specialist is responsible for the Sterility Assurance of the manufacturing processes, processing areas and product through implemented site wide compliance programs managed by the team
Leading as SME specific subject(s) as part of the Contamination Control SOP in her/his area of expertise
Conducting risk assessments related to contamination control
Overseeing site activities and performance for contamination control systems in her/his scope of responsibilities
Leading investigation following contamination control failures and propose corrective and preventive actions (CAPA)
Collaborating with cross-functional teams to ensure product quality
Ensure presence on the shop floor to oversee practices, identify gaps vs SOP for contamination control
Reviewing data from contamination control monitoring to propose improvements as necessary (from monitoring and trends)
Participating in audits and regulatory inspections and audits, providing expertise on sterility assurance and microbiology
Supporting the preparation of validation protocol and support project related to her/his area of expertise
Contributing as an SME to specific CoE/CoP with Global functions; implementing on site the best practices shared
Advise on sterility assurance & microbiological protocols and procedures
Propose corrective and preventive actions to improve contamination controls
Advise cross-functional teams on best practices or expected improvements in her/his area of expertise
Presence on the shopfloor with formal traceability of the observations; Inform management and feedback operators
Contribute to quality documentation SOP and validation protocol
Follow site and global HSE guidelines
Provide oversight and technical direction EM, Contamination Control and Utility Sampling programs
Ensure timely review, approval of Critical Utility and Environmental Monitoring trend reports for area(s) of responsibility
Provide oversight and technical direction associated with execution of APSS, EM area qualification and ISO certification
Review and approve applicable departmental flow and engineering diagrams as needed
Provide Quality decisions and assessments to support shopfoor/ investigations, as related to Sterility Assurance Programs.
Perform sterility assurance related Change Control Requests, CAPAs
Acts as a Change Control Sterility Assurance assessor and CAPA QA expert
Provide technical training on contamination control, as required
Participate, as a Quality representative, on facility, environmental and sterility assurance continuous improvements and strategic Site projects
Leads Sterility Assurance continuous improvements for the APU and acts as a Quality representative on APU / Site strategic projects as it pertains to Sterility Assurance.
Additional duties as required