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Shoppers Drug Mart®/Pharmaprix®

Specialist, Quality Assurance

243 Consumers Road, Toronto, ON Full time

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.

Why this role is important?

Why is this role important :

Reporting directly to Director, 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.

What you'll do:

Working closely within the e-Commerce Operations, distribution center and external suppliers, the Quality Specialist will deliver the following:

 

  • 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 center (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 center

    • Liaise between suppliers and distribution centers in obtaining product stability information/ assessment from suppliers and issuing product disposition to distribution center QA in the event of temperature excursion impacting/potentially impacting products

    • Investigation of product complaints as it relates to product handling at the distribution center 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 center 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 center

    • Perform other Quality and Regulatory duties, as assigned

    • undefined

    • 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 center

      • Verify accuracy of article set-up corrections in SAP

      • undefined

      • Internal/External Quality/Regulatory Audits

        • Conduct internal regular audits of LCL and SDM e-Commerce websites and apps, Instacart, PC Express, SDM.ca, 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

        • undefined

        • Support GMP, regulatory and vendor audits/inspections

  • Must have functional knowledge of product development of finished goods and retail products. Including key understanding of various manufacturing techniques, knowledge of related ingredients and properties in various applications, knowledge of process parameters that impact final product and any applicable industry standards and regulatory requirements.

  • Work with product development and vendor to support the development of technical, accurate and comprehensive manufacturing and finished product specifications which take into consideration vendor operating standards and customer expectations.

  • Provide proficient technical insight to conduct a detailed product risk assessment throughout the projects to ensure that all risks to the performance of the product from a quality and food safety perspective are considered and recommendations are provided to attain a high level of compliance.

  • Work with vendor to conduct appropriate review of ingredient specifications, allergen controls, packaging, operational controls and other applicable validation studies to assess food safety and quality risk mitigations

  • Attend productions events, conduct sample evaluation, review product analysis reports, and customer complaints to ensure product quality consistency, sensory and alignment to specifications to determine vendors capability of a successful launch through the warranty period.

  • Act with pace and efficiency during investigations and ensure timely resolution of customer complaints, trends and non-conformances ensuring that root cause analysis and corrective/preventative actions are implemented.

  • Commitment to promoting a workplace of inclusiveness and belonging

What you bring:

This position requires a high level of initiative and judgment in order to organize and prioritize tasks, workload and projects. A strong ability to influence while maintaining courtesy, tact and diplomacy is required in dealing with colleagues in every day working relationships.

  • 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 Schedules), Medical Device Regulations, Natural Health Product Regulations, the Narcotic Controlled Regulations, Controlled Drugs and Substances Act, Benzodiazepine and Other Targeted Substances Regulations, Precursor Control Regulations

Additional Skills and Experience:

 

  • Requires an ability to apply concepts and theories to improve functions or units.

  • Requires specialized interpersonal skills to resolve situations with colleagues where there may be some level of conflict, stress or uncertainty.

  • Provides solutions by using imaginative approaches where constructive and critical thinking and innovation are required.

  • Utilizes decision making skills to achieve specific organizational objectives with consideration given to their impact on other work groups.

  • Adaptable to set and prioritize work with varying exceptions.  Able to work with diverse personalities and styles.

  • An understanding of Quality Assurance policies and procedures in a manufacturing, supply chain/logistics environment

  • Ability to handle sensitive issues requiring timely completion of documentation in order to control deficiencies and expedite product dispositions

  • Knowledge of compliance and regulatory components, auditing skills, and quality systems

  • Interpret Health Canada GMPs and other Guidelines and regulations, NAPRA and Provincial Drug Schedules, PIC/s, corporate policies/standards to determine SDM position regarding quality processes, compliance requirements

  • Maintaining quality and patient safety first while recognizing the importance of good business decisions

Why work at Shoppers Drug Mart?

Acting as consultants, supporting internal customers and the Associate-Owners, you will get experience unique to the retail industry while working for an award-winning national brand.   Benefit from a purchase discount program, competitive pay and online learning through Academy.

Take ownership of your work and find more ways to care about your work, co-workers, customers and community.

How You’ll Succeed:

At Shoppers Drug Mart Inc., we seek great people to continually strengthen our culture.  We believe great people model our values, are authentic, build trust and make connections. 

If that sounds like you, and you are open-minded, responsive to change and up to the challenges provided in a fast-paced retail environment, apply today. 

Employment Type:

Full time

Type of Role:

Regular

Shoppers Drug Mart Inc. recognizes Canada's diversity as a source of national pride and strength. We have made it a priority to reflect our nation’s evolving diversity in the products we sell, the people we hire, and the culture we create in our organization. Accommodation is available upon request for applicants with disabilities in the recruitment and assessment process and when hired.

In addition, we believe that compliance with laws is about doing the right thing.  Upholding the law is part of our Code of Conduct – it reinforces what our customers and stakeholders expect of us.

Please Note: If you have Employee Self Service (ESS) on Workday, apply to this job via the Workday application.

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