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TPW \ QC Sterility Manager

Location: Toronto, ON, Canada

Job Category: General Services Jobs

Requisition Number: 35750

TPW / QC Sterility Manager-35750




Reference #35750 (DS)

Sanofi Pasteur Limited is looking for a knowledgeable and results driven individual to join our Site Quality Operations team as Manager Sterility. This is a temporary assignment for approximately thirteen (13) months. Reporting to the Deputy Director, Microbiology QO QC, this individual will supervise various testing activities within the Quality Control (QC) Sterility group, including planning and scheduling to ensure efficient and effective sterility testing support of in process and finished products. Key responsibilities will include the following:

1. Supervise sterility testing of products to ensure efficient and effective testing. Responsible for maintaining departmental testing records ensuring all staff follow quality and compliance procedures. Participate in internal and Regulatory audits.

2. Responsible for review and approval of testing records and ensure all documentation meets GMP, compendial and company standards. Utilization and support of data management/release systems.

3. Provide scientific support and lead changes to test methodologies/equipment. Serve as a model of good teamwork and provide high quality deliverables such as new study protocols and associated reports, technical data summaries/trending within agreed timeframes.

4. Coordinate and manage the investigation of non-conformances from initiation to closure to:

• ensure all appropriate subject matter experts are involved and contribute to the investigation

• liaise with their respective QO rep to provide a draft and final investigation report and supporting documentation

• identify root cause and ensure appropriate corrective/preventative actions are implemented

• review and approval final investigation report

5. Responsible for planning of lab testing activities, assuring all materials and resources are planned, equipment and lab areas maintained to support testing demands.

6. Train and motivate staff to perform required testing or activities. Provide coaching and guidance to direct reports. Responsible for maintenance of the lab training program and records. Responsible for administration activities and support hiring process of union staff, as required.


Qualifications Required:

• Master of Science degree in Microbiology or closely-related discipline, plus a minimum of five (5) years of previous relevant experience in an Industrial Microbiology laboratory.

• In depth knowledge of QC microbiology techniques and compendial standards.

• Sterility testing experience.

• Attention to details and experience in data interpretation and documentation review.

• Knowledge of analytical method development, test transfer, and method validations.

• Knowledge of the failure investigation management system and change management system.

• Good knowledge of GMP requirements and experience with regulatory audits.

• Experience in leading projects/teams.

• Strong interpersonal and communication skills combined with solid problem solving and organizational skills.

• Solid computer and technical writing skills.

Qualified candidates may submit their on-line resume with cover letter to quoting reference Manager Sterility, Temporary (13 months), Ref. #35750(DS).

Sanofi Pasteur, the vaccine division of Sanofi Canada, is the largest company in the world devoted entirely to human vaccines. 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. 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 1,200 employees give us their best and we offer the best in return.

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.

Job : General Services
Primary Location : Canada-Ontario-Toronto

Job Posting : Feb 20, 2014, 11:31:40 AM

Shift : Day Job
Job Type : Temporary Work
Employee Status : Contractor/TPW

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  • About Sanofi Pasteur

    Sanofi Pasteur, the vaccines division of Sanofi, is a global company that provides more than one billion doses of vaccine each year, making it possible to immunize more than 500 million people across the globe. A world leader in the vaccine industry, Sanofi Pasteur offers the broadest range of vaccines protecting against 20 infectious diseases.

    The company's heritage, to create vaccines that protect life, dates back more than a century. Every day, the company invests more than one million Euros in research and development.

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