Sanofi Group OQ Shop Floor Manager in Toronto, Ontario
OQ Shop Floor Manager
OQ Shop Floor Manager
(PERMANENT EMPLOYMENT OPPORTUNITY)
Location: Sanofi Pasteur Limited / North York, Ontario
Reporting To: Deputy Director, Site Quality Operations
Required Education: Bachelor of Science, specializing in Microbiology, Biochemistry,Immunology or Pharmacology orMaster of Science in Microbiology, Biochemistry or Immunology
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.
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:
As a member of the Quality Operations, Operational Quality team, provide compliance support to Deputy Directors for the licensed product, teams in managing their day-to-day operations in compliance with Sanofi Pasteur quality systems requirements and Good Manufacturing Practices. The incumbent will provide Operational Quality support Deputy Directors for designated departments of Industrial Operations (such as: Bulk Manufacturing, Formulations Filling & Packaging, Media Services, Manufacturing, Quality Control, Global Engineering Maintenance, Materials Management/Logistics, Purchasing and Customer Service/Marketing, Manufacturing Technology, QOSA). The incumbent is expected to work independently as a QO Manager with a level of autonomy and authority for decision making as a delegate to the Deputy Director as necessary to drive process improvements, ensure ongoing compliance to requirements in the dossier, current GMPs, and also achieve process efficiencies.
Support the Operational Quality Deputy Directors in ensuring timely review, follow-up on, closure and approval of various documents from Quality Control and Technical Services; such as: master and executed batch records, operational log books, sterilization and depyrogenation records, SOP, SWI, deviation, protocols, reports, work orders, worksheets, maintenance task lists, that are within the scope or delegated.
Ensure failure investigations/deviations are processed and that problem resolution occurs prior to commitment date within SAP. Ensure that batch recommendations are based on sound science and supporting reports are of high quality. Ensure timely review of deviations, and approve notation and minor deviations and no overdue.
Perform the role of QO Representative in coordinating, investigating and assessing Change Control Requests (CCR’s) and CAPA for IO, as designated within this process. This activity will require the incumbent to determine if a change request impacts product and processes.
In addition, the incumbent might have to be a QO Representative at various internal and external committees and board related to the management of the organization, such as: Sanofi Pasteur Change Control Board, Material Review Board, QDCI (mandatory), FFast.
Ensure through shop floor presence and knowledge transfer, that there is in-depth GMP understanding as it pertains to specific operations and that issues are identified locally and dealt with through close collaborative contact with the various departments.
In conjunction with the QO Quality System Internal Auditor and Vendor Auditor, perform audits and support functions performing GMP activities to ensure compliance with cGMP standards, site and corporate policies.
Develop tools for performance monitoring and provide feedback to the departments supported both formally (departmental presentations) and informally (shop floor review) and obtain agreement on corrective actions as required.
Make assessment decision and authorization for processing / reworking, manufacturing at risk.
Perform data gathering and analysis of non-conformances to support annual product review.
Project team participation
Education & Experience:
Bachelor of Science degree specializing in Microbiology, Biochemistry, Immunology or Pharmacology with 5 years of relevant experience in Quality Operations from a Pharmaceutical or Biologics Manufacturing facility or
Master of Science degree in Microbiology, Biochemistry or Immunology with 3 years of relevant experience in Quality Operations from a Pharmaceutical or Biologics Manufacturing facility.
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 \
Applications received after the official close date will be reviewed on an individual basis.
Once selected for an interview, internal employees are required to notify their manager.
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: Oct 13, 2016, 4:03:34 PM
Job Type: Regular
Employee Status: Regular