Specialist, Quality Assurance

Location

243 Consumers Road, Toronto, Ontario, M2J 4W8

At Shoppers Drug Mart, we’re innovating health and wellness in Canada. From prescriptions to walk-in clinics, and a beloved loyalty program, we’re caring and supporting our customers in new ways every day.

With more than 1,300 locally owned and operated stores from coast to coast, the Shoppers Drug Mart network is more than a great place to shop, it’s a great place to work. We’re committed to building our talented team who champion collaboration, kindness and inclusivity. Join our team, and help recognize a healthy future for your career and for all Canadians.

Reporting directly to Manager, Quality Assurance, the incumbent will be responsible for implementing and maintaining quality and regulatory compliance with Canadian laws, Health Canada and Pharmacy regulations and guidelines applicable to the e-Commerce distribution businesses involving drugs, medical devices and natural health products.

• Provide support in the establishment, implementation and maintenance of quality systems including:
  • Development, authoring, and implementation of required Standard Operating Procedures (SOPs)
  • Maintenance of regulatory licences at the distribution centre (MDEL, DEL, etc.)
  • Identification of compliance gaps, develop and implement plans to address compliance gaps
  • Oversight of the Product Quarantine/Reject process at the distribution centre
  • Liaise between suppliers and distribution centres in obtaining product stability information/assessment from suppliers and issuing product disposition to distribution centre QA in the event of temperature excursion impacting/potentially impacting products
  • Investigation of product complaints as it relates to product handling at the distribution centre and transportation
  • Writing and investigation of CAPAs when non-conformances occur per Root Cause Analysis
  • Evaluate returned products and associated documentations and provide product disposition
  • Regulatory review of product marketing material
  • Tracking on completion of systems validation activities
  • Tracking, trending and reporting on Quality KPIs
  • Oversight and execution of FCA/Recalls at the distribution centre and provision of recall report to supplier, as required
  • Ensuring all respective personnel are trained and qualified on GMPs and respective SOPs
  • Preparation and collation of Quality Management Review presentations
  • Maintenance and organization of all quality documents
  • Support/Lead projects with quality/regulatory impact, as assigned
  • Regular visit to the distribution centre
  • Perform other Quality and Regulatory duties, as assigned
• Change Control (Internal and External)
  • Review and process change requests for e-Commerce product listing/de-listing
  • Determine and assign the drug schedules in accordance with current national and provincial government guidelines
  • Provide quality and regulatory impact assessment on process/equipment/supplier/material change requests from e-commerce distribution centre
  • Verify accuracy of article set‑up corrections in SAP
• Internal/External Quality/Regulatory Audits
  • Conduct internal regular audits of LCL and SDM e-Commerce websites and apps, Instacart, PC Express, , etc. ensuring compliance of product set‑up to current national and provincial pharmacy drug schedules
  • Prepare audit reports and follow‑up on issues identified ensuring timely and 100% completion of corrective/preventive actions
  • Support GMP, regulatory and vendor audits/inspections

• Minimum 1 to 3 years working experience in GMP pharmaceutical industry in Quality Assurance
• Must have a Bachelor of Science (or Canadian Equivalent)
• Understanding of Health Canada GMP and other related guidelines, Canadian Pharmacy regulations (e.g. National and Provincial Drug…