TORONTO, ON
CONTRACT: 12-18 MONTHS
FROM $47/HOUR
The Senior Quality Assurance Specialist holds primary responsibility and accountability for providing comprehensive quality oversight of all product distribution activities within Canada. This pivotal role specifically manages GMP release of products, ensuring strict adherence to company’s SOPs, internal policies, and relevant industry guidance.
RESPONSIBILITIES
· Take ownership and provide support on QMS processes (Deviations, CAPA & Change Controls), including Root Cause Analysis, Risk Assessment, Action completion, and timely closure of records.
· Support the intake, triage, and logging of deviations & distribution complaints into the electronic Quality Management System
· Ensure that Canadian quality system documents, SOPs, Quality Agreements, SMFs, are compliant, up to date and accurate
· Prepare materials for distributor sites to monitor performance on deviations, cascade information and follow up on outstanding items
· Manage the release and Batch certification of all the products for sale to the Canadian Market
· Raise risks/issues with timelines and seek support in timely resolution
· Support products Recall in Canada and annual Mock Recall as per the Global schedule
REQUIREMENTS
· Bachelor’s Degree, preferably in life sciences or a technical discipline – preferably Degree in pharmacy, chemistry, medicine, biology, or a related life science.
· Expertise in GxP Regulations, demonstrated working knowledge and practical application of Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP). This includes deep familiarity with Canadian, US and international/global regulatory requirements and associated guidance documents and standards across diverse modalities (e.g., small molecule, device, biologics, cell & gene therapy).
· Direct experience with the GMP release of pharmaceutical products
· Experience with processing deviations and CAPA in an electronic QMS tool such as Veeva or equivalent
· Excellent verbal and written communication skills with a high level of attention to detail
· Veeva electronic Quality Management System (VeeQMS).
· Clean criminal background
Please submit your resume asap
