Making a difference, one role at a time.
Located in the heart of the Cité de la Biotech in Laval, Kedrion Biopharma Canada's mission is to make rare connections that impact millions of lives. Our team is developing an innovative treatment based on plasma-derived proteins, offering a new path of hope to children and adults suffering from orphan diseases. We're turning innovation into real solutions to save lives.
JOB DESCRIPTION
Do you want to bring your expertise in quality assurance to a dynamic and rigorous environment? Join Kedrion Biopharma Canada as a Specialist, Quality Assurance and help ensure product quality in accordance with pre-established specifications.
More specifically, you will be responsible for:
- Manage and maintain the training program within the Quality Management System.
- Develop training programs in compliance with standards (GMP/GDP, pharmacovigilance, etc.).
- Identify training needs according to positions and departments.
- Deliver training (including, but not limited to, GMP/GDP training for new employees, pharmacovigilance). This includes preparing training materials and assisting in the development of the training schedule.
- Create courses for global procedures and courses requiring a new trainer in MasterControl.
- Ensure the management and compliance of the documentation system and quality processes (writing/reviewing SOPs, monitoring deviations, OOS, CCR, CAPA, audits, and implementing global policies) in accordance with GMP standards and regulatory requirements.
- Support Quality Assurance activities and site governance (quality review, regulatory monitoring, audit preparation, data entry in quality tracking tools) while consistently applying Health and Safety rules.
You are the right person for this role if you have:
- Hold a Bachelor's degree in Chemistry, Biochemistry, Biology, or another relevant field.
- 3 to 5 years of experience in the pharmaceutical or biotechnology industry.
- Direct experience in supporting and conducting theoretical and practical training sessions (GMP and GDP).
- Excellent presentation and oral/written communication skills, including group facilitation and delivering content in both official languages (French and English).
- Proficiency in computer tools and training software (MS Office, PowerPoint, Excel, MasterControl).
- Good knowledge and understanding of GxP Canadian regulations, U.S. (FDA), and European GMP regulations, with experience in ICH guidelines.
- Experience with commercial quality systems (1 to 3 years).
- Strong knowledge of GMP and pharmaceutical regulations.
- Experience in delivering both theoretical and practical training sessions, as well as the application of adult learning principles.
- Planning and coordination of training programs.
Kedrion offers you:
- A fantastic team that strives to do things in the best possible way.
- A relaxed working environment.
- A start-up culture that values autonomy, innovation and collaboration.
- A competitive salary and benefits package.
- A unique opportunity change lives through your commitment and contribution.
Knowledge of French is required for positions permanently located in Quebec so incumbents can communicate with their colleagues and suppliers in Quebec as necessary.
Other language requirement
Another language is required for this position in order to communicate with partners and colleagues, who are predominantly located outside Quebec and to understand the technical and scientific documentation used in our industry.
Kedrion Biopharma Canada is committed to equal employment opportunities.
For more information, visit our website: https://www.kedrion.ca/
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