Sanofi Group Technical Manager Quality Operation Sterility Assurance Contamination Control - VIE (W/M) in Toronto, Ontario
iMove, the Sanofi VIE Program, is available to citizens of the European Economic Area (EU + Norway, Liechtenstein and Iceland) aged between 18 and 28.
PLEASE NOTE that since this program is primarily an international development program, candidates cannot apply to a VIE assignment in their own country of citizenship.
PLEASE NOTE that applications that are only submitted in French cannot be considered by our non-French speaking partners at Sanofi worldwide.
Therefore, only applications that are submitted in English will be considered.
At Sanofi diversity and inclusion is foundational to how we operate and is embedded in our Core Values. We respect the diversity of our people, their backgrounds and experiences. 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 employees, patients and customers.
We are looking for a candidate for a VIE mission of:
Technical Manager Quality Operation Sterility Assurance Contamination Control - VIE Contract (W/M)
During your VIE assignment you will:
Manage the contamination control program (60%)
Provide oversight and technical direction to ensure the environmental monitoring program along with the cleaning and disinfection regime are executed in accordance with company standards and regulatory requirements:
Review and approve contamination control related documents (include but are not limited to Standard Operating Procedures, validation / support study protocols / reports, and technical documents such as drawings and specifications)
Perform routine review of environmental data with the support staff and management (plus issuance of environmental certificates for batch release)
Make improvements, where necessary, to ensure robust monitoring processes (i.e. efficient, effective, and compliant)
Perform periodic shop floor surveillance
Provide Quality direction and approvals to assure environmental conditions and sterile assurance practices for manufacturing are in a state of control
Assess contamination control related Change Control Requests
Provide leadership to ensure robust investigation of environmental excursions and incidents:
Assure the investigation is timely, thorough, scientifically sound, and supported with relevant documentation
Perform risk assessment, data / trend analysis, when required
Assure corrective and/or preventive actions are adequate and appropriate (aim to reduce future occurrence of environmental excursions / deviations / events
Review and approve the environmental investigation reports
Prepare and/or present findings and recommendations to upper management for review and approvals, when required
Provide technical training on contamination control, when required
Participate, as Quality representative, on facility / environmental related projects
Support inspection readiness activities (20%)
Assure the contamination control program is in a state of compliant and inspection ready
Prepare inspection readiness packages
Defend the contamination control program during internal and external inspections
Participate in responding to audit observations and implement corrective action(s) in a timely manner
Support continuous improvement to the sterility assurance program (20%)
Participate in sterility assurance improvement projects
Establish specifications and/or prepare related study protocols and reports, when required
Develop, revise, review and/or approve sterility assurance related policies and procedures
Master Degree in Science in Microbiology or Applied Pharmaceutical Sciences / Engineering
Minimum 1 year of work experience in Good Manufacturing Practices regulated industry with direct contamination control experience (include heating, ventilation, and air conditioning (HVAC) systems, quality design and validation of cleanroom, cleaning and disinfection)
Sound knowledge on sterile drug manufacturing (e.g. fermentation and aseptic filling, various methods of sterilization, and various types of aseptic applications such as Restricted-access barrier systems (RABS) and isolator technologies)
Proficient in computing (include MSWord, Excel, PowerPoint, Visio, etc.) and in performing risk and trend analysis
Team player with good communication skills
Fluent English both written and verbal
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.
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