Sanofi
AsepticProcessingProfessional
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“Aseptic Processing Professional at Sanofi. Skills: GMP documents, Quality Systems, change control, aseptic processing. Prepare and update GMP documents. Assist in maintaining GMP documents”
What You'll Achieve.
close gaps within the required timeframe; ensure minimal impact to production activities; improve trends in controlled areas
Industry & Context.
travel within Canada and globally
What They're Looking For.
Must Have
Bachelor's degree in Science / Engineering or in a related field, 1 -3 years of experience, interpersonal skills, verbal and written communication skills
What You'll Do.
Prepare and update GMP documents
Assist in maintaining GMP documents
Participate/oversee implementation of component specification documents
Provide project management support
Filling representative for Site Wide Initiatives
Perform and/or participate in GQD gap analysis
Implements Corrective and Preventative Actions
Identify opportunities for alignment
Coordinate the media simulation operation
Support the Environmental Monitoring program
Serve as coordinator with other service provider departments
Assist in routine revalidation/non-routine validation activities
FFaST Lead: Conduct monthly discussion forum
Develop training plan and maintain training database
Hold training sessions
Role of system administrator
Initiate and manage change control requests
Collaborate with assessors for evaluation
Ensure timely closure of change controls
Support Lead Investigators and Filling Platform
How You'll Work.
Team & Collaboration
work within Sanofi manufacturing and Quality Systems; work with QOSA review broth protocols; communicate and serve as liaison; work with shift managers and filling group leaders; coordinate with QOSA to implement CAPA; Collaborate with assessors for evaluation of changes; Support Lead Investigators and Filling Platform
Communication Scope
verbal and written communication skills
Process & Methodology
project management support on compliance related activities, continuous improvement projects
Full Job Description
**Reference no. R2855279** **Position title:** Aseptic Processing Professional **Department:** FFIP Pandemic Flu Filling **Location:** Toronto, ON Fixed Term; 12/24/2027 **About the Job** 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. This role will manage projects affecting the Filling platform in relation to compliance and continuous improvement projects. This role will also act as a technical resource person who uses cleanroom and aseptic processing knowledge to work within Sanofi manufacturing and Quality Systems to support Filling in the context of change control lead, CAPA owner, SME for global projects, and regulatory audits. **About Sanofi** We’re 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. ** _Main Responsibilities:_** **Technical Writing (70%)** * Prepare and update GMP documents such as SOPs, SWIs, protocols, reports. * Assist in maintaining GMP documents to meet compliance standards and alignment with Global Quality Directives. * Participate/oversee implementation of component specification documents. **Quality/ Project Management Support (15%)** * Provide project management support on compliance related activities and continuous improvement projects specific to Filling, with the aim to close gaps within the required timeframe and ensure minimal impact to production activities. * Filling 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 Filling Departme
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