Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche, where every voice matters.
The Position
A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Crafting a world where we all have more time with the people we love.
That’s what makes us Roche.
The Quality Management Intern works collaboratively with the Quality Management (QM) team, Health Canada, and Roche internal networks (local and global) to support compliance of processes and products to Pharma Quality System (PQS) and Health Canada requirements. Responsibilities may include management of documents, reviewing documents, supporting batch release, supporting licensing activities, collaborating closely with other teams and supporting quality projects. QM Intern may also undertake other ad-hoc work or projects.
QM Intern will gain knowledge and understanding of Canadian Regulations, Good Manufacturing Practices (GMP and Medical Device) regulations to support compliance activities of Roche Canada.
The Opportunity:
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You are supporting the QM team to acquire and review all required documentation for releasing products (commercial and clinical products) to the Canadian market ensuring compliance with regulatory requirements
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You are helping to monitor group email accounts as this is essential in ensuring the work is well organized and performed.
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You are learning and understanding global PQS directives and Health Canada GMP requirements to help ensure the activities you are supporting meet their expectations
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You are assisting in the maintaining of both our Drug Establishment License and our Medical Device Establishment License.
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You are learning and supporting the team with change control and deviation processes as required
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You are supporting the team by learning about critical processes and helping maintain required documentation ensuring they are consistently meeting both Health Canada and Roche requirements.
Who you are:
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You hold a Bachelor's Degree in science.
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You are working towards a Quality and Regulatory Affairs Certificate program, such as the one offered by Seneca or Humber.
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You have a general understanding of Health Canada regulations and guidelines.
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You have strong communication, problem solving, time management and interpersonal skills
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You possess the ability to adopt agile mentalities and behaviors and integrate them into your daily tasks.
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You have the ability to work efficiently and collaboratively within a high-performing team environment and be an integral member of a self-managing team.
Additional Information:
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Duration (12 months), work term (Full time) and will begin in May 2025
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Location: Based in Mississauga, Ontario.
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Our team follows a hybrid work structure (minimum 3 days in the office).
This position is not eligible for relocation support.
Who we are
At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.
Roche Pharma Canada has its office in Mississauga, Ontario and employs over 850 employees. The Mississauga facility is bright, vibrant, fosters collaboration and teamwork, and is reflective of Roche's truly innovative culture.
Roche is an Equal Opportunity Employer.
