F. Hoffmann-La Roche Ltd
Location
Mississauga, ON | Canada
Job description
Key Accountabilities
Support product release to Canadian Market
Support the Quality Management team to obtain and review all required documentation (e.g. CoA, CoM, CoC, CPID, DEL) for releasing products (commercial and clinical drug products and medical devices) to the Canadian market ensuring compliance with regulatory requirements
Track and monitor group email accounts
Source and maintain required release documents from Roche and 3rd party sites
Learn and understand global PQS directives and Health Canada GMP requirements when sourcing and/or updating documents to support release of batches to the Canadian market to be in compliance with the Regulatory Requirements
Support Licensing and Vendor Management Activities
Assist with maintenance of the Drug Establishment License (DEL) and Medical Device Establishment License (MDEL) and assist with local and global changes incorporated into the applicable license
Support with quality agreements reviews, updates as well as audits as required.
Documentation Management
Assist team with updating required documentation, and work closely with team members to learn critical processes
Understand and consider global PQS directives as well as local GMP requirements when contributing to updates of local procedures
Support Process Performance and Quality Monitoring Systems
Learn and support the processes of Planned Events (PE) and Unplanned Events (UPE). It might include Change Controls, Complaints and Deviations
Ensure activities are performed in a timely manner and reported as part of the KPI (Key Performance Indicators) process
Development and Evolution of Team
As part of the GxP QM team, learn about how the team operates, from a self-managing perspective, as well as what it means to be a high performing team.
Education / Skills / Knowledge / Experience Required:
Must hold a Bachelor’s Degree in related field
Must be currently enrolled in a post graduate degree/diploma program in Quality Control or Quality Assurance or similar.
Must be available to work full-time (35 hours per week) during 12 months.
Ability to adopt agile mindsets and behaviors and integrate into daily tasks
Ability to work efficiently and collaboratively
Strong interpersonal and communication skills
Ability to communicate effectively
Strong problem-solving skills
Strong time management and planning skills
Strong presentation skills
General understanding of Health Canada regulations and guidelines
Additional Information
This position is a 12-month work term (full-time) and will begin in May 2024.
This internship position is located in Mississauga.
Our team follows a hybrid work structure (minimum 3 days per week in the office).
Relocation benefits are not available for this job.
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.
As of January 4, 2022, Roche requires all new employees who work in Canada to be fully vaccinated against COVID-19 on the date they take office. This requirement is a condition of employment at Roche that applies regardless of whether the position is on a Roche campus or remotely. If you have a valid reason for not being fully immunized, which is limited to certain specific medical reasons or other valid reasons protected by applicable human rights laws, you may request an exemption and / or adaptation measures regarding this vaccination requirement.
Roche is an Equal Opportunity Employer.
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