Location: Sanofi Pasteur Limited / North York, Ontario
Department: QC Raw Materials
Required Education: Minimum four (4) year University Bachelor's Degree (Biochemistry, Chemistry, Microbiology).
Temporary Position: Six Month Contract
About Sanofi Pasteur
Sanofi Pasteur, the vaccines division of Sanofi, is the largest company in the world devoted entirely to human vaccines. Our driving goal is to protect people from infectious diseases by creating safe and effective vaccines. Our company distributes more than 1 billion doses of vaccine each year, making it possible to vaccinate more than 500 million people across the globe. Sanofi Pasteur offers the broadest range of vaccines in the world, providing protection against 20 bacterial and viral diseases.
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.
1. Perform inspection, verification and applying labels for incoming quality inspected materials:
· Inspect incoming materials for damage and discrepancy.
· Verify and exam materials according to the requirements in the effective procedure and specifications.
· Download, assess and report the temperature date for the received material, where applicable.
· Prepare the appropriate documentation as per the appropriate SOP and specification.
· Prepare and apply bar-coded labels to inspected/verified materials.
· Responsible for using the current effective documentation.
· Responsible for verifying co-workers data if applicable.
· Perform related SAP entries for inspection step.
· Report discrepancy and non-conformance observations to manager.
2. Perform sampling for chemical and other required materials:
· Prepare the appropriate documentation as per the appropriate SOP and specification
· Perform sampling as per the appropriate SOP and specification
· Perform tests (if applicable) as per the appropriate SOP and specification, i.e. visual appearance of solution and volume check tests for media and reagents, etc.
· Deliver collected samples to the appropriate lab/areas as required.
· Responsible for using the current effective documentation
· Responsible for recording all tasks and tests performed in the appropriate documentation.
· Perform related SAP entries for sampling step.
· Responsible for verifying co-workers data if applicable
· Report discrepancy and non-conformance observations to manager.
3. Perform sampling and testing for packaging materials:
· Perform sampling of the received material as per the appropriate SOP and specification.
· Perform visual defect and physical measurement tests for primary packaging components (i.e. vials, stoppers, seals) using caliper
· Perform text, style, fold, color verifications, barcode scanning, etc. for secondary packaging components (labels, leaflets, cartons, corrugates, etc.)
· Review supplies Certification of Analysis.
· Perform related SAP entries for sampling and testing steps.
· Deliver collected samples to the appropriate areas as required.
· File and maintain approved artworks in the filing cabinet
· Report non-conformance event to manager as required.
4. Perform environmental monitoring and cleaning/disinfection of material and area:
· Perform cleaning and disinfecting of the materials, work surface, equipment and facility as required in the area procedures.
· Perform Environmental Monitoring (EM) based on approved procedures. Routine EM includes Passive, Viable Airborne, Total Airborne Particle Counts, Active Viable Airborne and Viable Surface
· Complete documentation associated with EM.
· Enter samples information in programs such as Master, PharmNet-Web, etc.
· Accountable for checking the Rapid/FMS System for data in environmental conditions prior to commencing work in the area
· Responsible for entering accurate information into logbooks.
· Responsible for recording all tasks performed in the appropriate documentation.
5. Maintenance of quality systems, i.e. adherence for GXPs, Safety, training, monitoring, and maintaining documentation, facilities, equipment, process, etc:
· Responsible for adherence to GXP, Safety guidelines as per corporate and site policies.
· Responsible for verifying equipment/instrument are certified/calibrated prior to use.
· Participate in the monthly cleaning of work areas.
· Participate in the cleaning of work area and warehouse as required for inspection readiness program
· Responsible for general maintenance of work area including cleaning/disinfection of facility, equipment maintenance, and disposal of waste.
· Ensure the appropriate cleaning/equipment logs or other related records are completed and maintained as per the established procedures.
· Monitor and maintain inventory of cleaning/sampling supplies
· Responsible for maintaining training record are up to date.
· Responsible and participate in training if assigned as qualified trainer.
Education and Experience:
· Minimum four (4) year University Bachelor's Degree (Biochemistry, Chemistry, Microbiology).
· Minimum of eighteen (18) months of previous relevant experience in a biological, biotechnology or pharmaceutical manufacturing company.
· Strong problem solving ability and attention to detail.
· Demonstrated ability to work independently and make quick decisions in accordance with SOPs and training.
· Well developed computer skills and the ability to enter and maintain accurate data and in a timely manner.
Hours of Work:
Monday to Friday 3 p.m.- 11 p.m.
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.
Applications received after the official close date will be reviewed on an individual basis.
NOTE: Internal applicants are required to notify their manager of their application.
Sanofi, Empowering Life
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.