Reference No. R2679608
Department: Sterility Assurance Programs & Site Support
Sanofi’s global vaccines business unit partners with the public health, medical and scientific communities to improve access to life-protecting vaccines and increase vaccination coverage, while striving to develop new and improved vaccines to enhance health and well-being.
At Sanofi, we chase the miracles of science to improve people’s lives. We believe our cutting-edge science and manufacturing, fueled by data and digital technologies, have the potential to transform the practice of medicine, turning the impossible into possible for millions of people.
The purpose of this QO technical position is to support the Sterility Assurance training program on site by providing theoretical and practical training that is maintained through continuous quality oversight. The role ensures that the OQ-SA Training Program for aseptic operators is comprehensive and that the training modules and specialized training courses for Contamination Control are in compliance with current company standards and regulatory requirements. In addition, this position requires the incumbent to support the management of environmental monitoring systems used on site. This position requires on-going collaboration with key stakeholders within Sanofi Pasteur.
QOSA Training Program
• Develop, execute and maintain Contamination Control training modules for cleanroom practices and behaviours, aseptic gowning, microbiology, cleaning & disinfection, environmental monitoring sampling and aseptic operator personnel broth.
• Develop, execute and maintain specialized training courses that result through revised regulations, manufacturing and site-specific requirements, CAPA’s and new technologies.
• Ensure adequate planning and preparation of training material and that in-class instruction is detailed, current and effective.
• Manage all training documentation in collaboration with IO Training and Development.
• Ensure all site/departmental SOPs are aligned with the OQ-SA Training program (aseptic gowning, personal broth, environmental monitoring sampling methods).
Aseptic Operator Quality Training Oversight
• Perform, assess and maintain aseptic operator initial qualification and annual re-qualification program for gowning
• Assess and perform the required training /re-training as assigned through environmental monitoring investigations, OQ-SA surveillance program, non-conformances, regulatory responses, CAPA actions as applicable.
• Perform and document aseptic operator surveillance of best practices and conformance of gowning practices and aseptic behaviours within the cleanroom environment. Prepare and/or present findings and make recommendations (including potential risk on product) to upper management for review and approval, when required.
Environmental Monitoring Systems
• Support management of environmental monitoring systems by performing administrative and routine maintenance activities as required.
Inspection Readiness & Sterility Assurance Continuous Improvement Program
• Prepare inspection readiness packages, summary overviews/presentations on the metrics/status of the QOSA Training Program.
• Ensure that the QOSA Training Program is in a state of compliance and inspection ready.
• Defend the QOSA Training Program during internal and external inspections.
• Participate, as Quality representative in Sterility Assurance improvement projects.
• Assess and/or approve Sterility Assurance related Change Control/CAPA requests.
Scope and dimensions
Breadth of responsibility (global/regional/country/site):
Key dimensions: headcount (direct and indirect) budget, doses, Capex… – Key indicators on which the job holder will be evaluated:
• The current QOSA Training Program covers both Industrial Operations and Process Development facilities on site:
o Approx. 100 operators required to be trained to enter 20 aseptic production platforms in 7 facilities
o Completion of training requirements for aseptic/classified area operators must be adhered to in order to facilitate production demands and capacity planning.
o Impact of incorrect assessment and/or conclusion on aseptic operator/processing training could impact risk and/or far reaching consequences on product quality and regulatory compliance.
Freedom to act, level of autonomy:
• Minimum B.Sc. in Microbiology or Applied Pharmaceutical Sciences.
• Minimum five years’ work experience in GMP regulated industry with direct contamination control experience ( include HVAC systems, quality design and validation of cleanroom, aseptic gowning, cleaning and disinfection, environmental monitoring).
• Act for Change, Cooperate Transversally, Strive for Results, Commit to Customers.
• Certification relative to in-class training and presentations an asset.
• Sound knowledge on sterile drug manufacturing (e.g. fermentation and aseptic filling, various methods of sterilization, and various types of aseptic applications such as RABS and isolator technologies).
• Proficient in computing (include MSWord, Excel, PowerPoint, Visio, etc.) and in performing risk and trend analysis.
Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.
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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.
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