Sanofi Group Technical Administrator in Toronto, Ontario
Reference No. R2596303
Position Title : Technical Administrator
Department : Bulk Manufacturing: Adsorptions
Duration : Temporary - 18 Month Contract
Location : Sanofi Pasteur Limited, Toronto, Ontario
Sanofi Pasteur: The world’s leading vaccine company
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.
Major Activities of the Job :
Change Control Request Leader:
Facilitate and track the change throughout the Change Control process.
Identify any additional areas that need to be included in the assessment (beyond the required assessors). This may be done in conjunction with SQO CM.
Engage all the areas to complete the assessment and to gather input for the action plan (AP)
and risk assessment with estimated cost.
Identify, in conjunction with the assessors, all GMP documentation and/or systems (includin but not limited to Raw Material Specifications, Master Product Specifications, SOPs, BPRs, SWis, Validation documentation, LIMS, SAP and Product Licenses) impacted by the change ensure their update and alignment as part of the action plan.
Develop and prepare the action plan together with Assessors and Action Item Owners to gain agreement and commitment to perform the required tasks in the time specified.
Finalize the Risk Assessment (i.e., assess risks to implement the change) with estimated cost based on information received from SMEs and/or Assessors.
Develops a Control Plan, when required for the CCR, together with System Owner, QO Representative and SMEs.
Ensure execution of the action plan and control plan including documentation, deliverables a completion dates.
Update and revise action plan if required including requesting a CCR modification. Provide all required information to close CCR (or multi-pati) and notify appropriate QO
Representative and SQO CM when tasks have been completed.
Implement change after closure of CCR (or multi-part).
Provide all required information to close Control Plan and notify appropriate QO Representative and SQO CM when control plan tasks have been completed.
Lead Investigator QNs :
Responsible for the overall investigation strategy from initiation to closure
Collaborate with QO, SME and LI from other departments to determine scope and strategy of investigation
Collect data and write/review drafts for non-conformance reports
Ensure the investigation is conducted within the specified timeframes and general requirements
In collaboration with Management identify and develop appropriate CAPA to address the root cause
Create and manage associated CCRs
GMP Documentation :
Create, revise, update and review SOPs, SWis
Revise, update and review Master BPRs
Review production BPRs for completion and accuracy
Review Protocols, Studies and Reports
Perform review and sign off of departmental log books
Order official copies of SOPs, SWis and maintain documents to ensure official copies are up- to-date
Train staff on new and updated SOPs, SWis and BPRs
Production Support :
Testing vent filters
Maintenance of reference and official reserve samples, entering samples into sample log books
Monitor refrigerators and incubators using chati recorders and FMS Deliver QC test Samples
Perform Environmental Monitoring, enter in Master system, deliver samples
Manage tank weighing and set-up in tank room during manufacturing
Administrative Support for Production :
Contact for support departments
Active and available during inspection readiness and inspection activities. Verification of compliant work area prior to and during inspection
Participate with and provide support to other departments in relation to problem solving and process improvement
Minimum Qualifications :
Minimum three (3) year College Diploma (Microbiology, Biochemistry, Specialty Technologist Programs)
Preferred three (3) year University Bachelor’s Degree (Biology, Microbiology, Biochemistry, Cell Science, General Science), plus a minimum of twelve (12) months of previous relevant work experience.
Manufacturing shop floor experience in area is an asset.
Advanced knowledge of Microsoft Suite programs and GEODE+.
Knowledge in the utilization of Phenix is an asset.
Experience working with Change management tools such as Trackwise.
Ability to work independently and to meet deadlines effectively.
Hours Of Work :
- Inclusive from: Monday – Friday: 8am – 4pm
Sanofi is an equal opportunity employer committed to diversity and inclusion. Our goal is to a ttract, 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.
Thank you in advance for your interest.
Only those candidates selected for interviews will be contacted.
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.