Sanofi Group Lead Investigator in Toronto, Ontario
Reference #: 70053404-1
Sanofi Pasteur, the vaccines division of Sanofi, is the largest company in the world devoted entirely to human vaccines. For over 100 years, we’ve provided life-saving vaccines for the prevention and treatment of infectious diseases.
Sanofi Pasteur Limited, located in Toronto, is one of the company's four major R&D and manufacturing sites. We are home to Sanofi Pasteur's North American centre for Analytical and Bioprocess R&D. As well, we are the largest Canadian vaccine producer: each year, we manufacture 50 million doses of vaccine and distribute them to more than 90 countries around the world, helping to protect against 20 infectious diseases. This variety of activities offers employees diverse opportunities for personal and professional growth. Our company attracts some of the best minds in the business from across the globe. Our 1,300 employees give us their best and we offer the best in return.
Our Sanofi Pasteur team in Toronto is growing!
Sanofi Pasteur Limited is looking for motivated and results driven individuals to join our Filling and Packaging team as a Lead Investigator. Key responsibilities will include the following:
Combining an understanding of process/facility equipment, biologic manufacturing process, cGMP, root cause analysis, and technical writing skills, the incumbent is responsible for identifying root cause of failures, writing and managing the non-conformance investigations, remediation actions and supporting the associated improvement for the Filling, Labelling and Packaging Platforms.
1.Investigate non-conformances associated with Filling, Inspection, Labelling and Packaging
Collaborating with QO, SME and LI from other departments as required, determine the scope of the investigation.
Develops an investigation strategy, with assistance of the above, as required.
Determines appropriate analytical tools, process walks and reviews or analysesrequired to determine root cause or identify all the possible root causes
Identifies expertise required for the investigation
Identify, co-ordinate and manage contributions from other departments
Participate in FFaST and Performance centre (PC) Action planning teams to ensure and follow planning and execution of investigation
Works with the QO Departments (sterility assurance, shop floor, validation) and collects data and writes/reviews drafts for non-conformance reports.Review/provide guidance in preparation of reports prepared by technical staff.
Support Manufacturing investigations associated with complaints and OOS
Support investigations in other platforms as required.
Support investigations of minor non-conformances and development of templates as required.
Extensive knowledge of aseptic filling operations, visual inspection, labelling and packaging in a pharmaceutical environment.
2.Develop and presents risk assessments
Working with SMEs and appropriate QO experts, develop assessment of risk to product, process and other stages
Present to Material Review Board as required
3.Develop appropriate corrective and preventative actions
In collaboration with platform management and other stakeholders, identify and develop appropriate CAPA to address the root cause.
Creates and manages associated Change Controls and CAPAs
Identify recurrent issues or themes and develop improvement plan with area management or other stakeholders
Work with FFaST, F&P production team and performances centre action planning teams to ensure actions are assigned to the appropriate departments /individuals and followed up on.
Review notations and minor non-conformances
Work with the Platform Leaders and Industrial Excellence to identify and develop process improvements to remediate risks, improve investigations or avoid future non-conformances
4.Write and manage associated documentation and timelines.
Responsible for the investigation report or manufacturing investigation report.
May delegate document or report drafting to appropriate involved individuals such as platform staff, SME’s etc.
Determines when investigations are complete and prepares the report for review and approval.
Manages the deviation/ investigation review process and ensures the Deviation eventis closed according to targeted timelines
Proactively manages dates by providing justification for extending closure dates of investigation to QO.
Develop and issue FF&P NC status reports.
Present and defend investigation in regulatory inspections and other reviews.
Bachelor’s degree in Applied Science or Engineering, or
Bachelor’s Science degree in relevant major with appropriate experience
· Experience in Pharmaceutical Manufacturing/Manufacturing Technology/Quality Operations, Engineering/Maintenance or similar role
· High level of knowledge of cGMP in pharmaceuticals/biological
· Good problem solving skills and documentation skills
· Must possess excellent communication and organizational skills
· Excellent technical writing skills
· Six-sigma or other root cause training and experience
· Knowledge and experience with multiple software programs such as SAP, Trackwise, Word, Outlook, Visio and PowerPoint
· Working knowledge of HSE and Quality Systems
Hours of Work:
Monday to Friday: 8:00- 4:00 p.m.
Qualified candidates may submit their resume with cover letter online viawww.sanofipasteur.caquoting \
Sanofi in Canada embraces diversity in the workplace and is committed to achieving employment equity. 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 applications from women, members of visible minorities, Aboriginal peoples and persons with disabilities.
Thank you in advance for your interest.
Only those candidates selected for interviews will be contacted.
We are an equal opportunity employer.
Follow Sanofi Canada on Twitter:@SanofiCanadaand on YouTube:youtube.com/user/SanofiPasteurCanada
Primary Location: Canada-Ontario-Toronto
Job Posting: Sep 16, 2016, 2:57:45 PM
Job Type: Regular
Employee Status: Regular