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.

Why this role is important?

The Specialist, Quality Assurance is responsible for developing, implementing, and maintaining the enterprise Quality Management Systems. This role supports the businesses in ensuring compliance with Canadian laws and Health Canada regulations and guidelines applicable to health products, including drugs, medical devices, and natural health products. The incumbent will work closely with enterprise Operations, other internal stakeholders, and external supplier

Duties and Responsibilities:

1. Quality Management System (QMS) Establishment & Maintenance

· Provide support in the establishment, implementation, and maintenance of quality systems.

· Develop, author, and implement required Standard Operating Procedures (SOPs).

· Maintain regulatory licences (e.g., MDEL, DEL).

· Identify and review applicable government, regulatory, and corporate policies to ensure all procedures are current and meet requirements; Identify compliance gaps, and develop and implement plans to address them.

· Ensure all respective personnel are trained and qualified on GMPs, complaint handling, and relevant SOPs.

· Perform regular visits to sites/distribution centers.

2. Product Quality Control & Disposition

· Oversee the Product Quarantine/Reject process at the site/distribution center.

· Liaise between suppliers and distribution centers to obtain product stability information/assessment.

· Issue product disposition in the event of temperature excursions impacting or potentially impacting products.

· Evaluate returned products and associated documentation, and provide product disposition.

3. Non-Conformances & Corrective/Preventive Actions (CAPA)

· Write and investigate CAPAs when non-conformances occur, utilizing Root Cause Analysis.

· Ensure timely completion and closure of Non-conformances/Deviations/CAPA reports.

4. Document & Record Management

· Identify and review applicable government, regulatory, and corporate policies to ensure all procedures are current and meet requirements.

· Identify compliance gaps, develop, and implement plans to address compliance gaps.

· Update/Develop SOPs ensuring timely implementation.

· Maintain and organize all quality documents.

5. Change Control (Internal & External)

· Review and process change requests for product creation, listing, and de-listing.

· Review/Provide/Approve quality and regulatory impact assessments on process/equipment/supplier/material change requests.

6. Audits & Inspections

· Conduct internal and external audits, prepare reports, and follow up on identified issues, ensuring timely completion of corrective/preventive actions and closure of audit reports.

· Perform internal GMP Self-Inspection: Audit and report on the GMP management system to ensure its ongoing effective application.

· Support Regulatory (e.g., Health Canada) inspections with the Director QA and Sr. Director QA.

7. Product Complaints Management

· Track and report product complaints to suppliers and follow up on corrections/corrective actions as needed.

· Investigate product complaints as required.

· Liaise for effective processing of complaints and return of complaint samples to suppliers as needed.

· Communicate corrections/corrective actions by supplier internally and to the site/distribution center as needed.

8. Supplier Quality Management

· Support supplier and/or material qualification (e.g., vendor audits, establishment of Quality Agreements, product review/assessment).

· Support the development and maintenance of Quality Agreements with suppliers.

9. Validation & Qualification

· Support the execution of the Validation Master Plan and validation protocols (e.g., process, equipment, facilities, software, material qualification) as required.

10. Regulatory Compliance & Reporting

· Perform regulatory review of product marketing material.

· Track, trend, and report on Quality KPIs.

· Report on compliance status of Quality Systems during Management Review Meetings.

· Report on status of quality goals and metrics during Management Review Meetings.

11. Field Corrective Actions (FCA) & Recalls

· Support development and execution of FCAs/Recalls.

· Oversee and execute FCAs/Recalls at the site, distribution center, and provision of recall reports to suppliers as required.

12. Project Management

· Support/Lead projects with quality/regulatory impact.

· Determine and timely execute/implement quality requirements per plan.

13. Other Responsibilities

· Support compliance and product release (if applicable) of importation activity for health products.

· Support compliance of medical device servicing and installation activity.

· Support other healthcare businesses as required.

· Perform other Quality and Regulatory duties, as assigned.

· Occasional travel to various SDM/vendor sites is required.

Skills and Experience:

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

· Communicates with clarity, verbally to conduct personnel training and in one on one or group situations, or over the telephone.

· Communicates well in writing by composing clear documents

· Able to work with minimal of supervision.

· Proficiency in all Microsoft Office applications (especially Excel, Word and PowerPoint)

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.

Hiring Range / Échelle salariale à l’embauche :

$60,000.00 - $82,500.00 / 60.000,00$ - 82.500,00$ (per year / par an)

A candidate’s experience and knowledge as well as the geographical region in which the position is located may be factored into the pay a candidate receives for this position. This posting is for an existing vacancy. The Company uses artificial intelligence for the purpose of screening, assessing and/or selecting applicants for this position. / L’expérience et les connaissances d’un candidat ainsi que la région géographique dans laquelle le poste est situé peuvent être prises en compte dans la rémunération qu’un candidat reçoit pour ce poste. Cette offre d’emploi concerne un poste vacant existant. L’entreprise utilise l’intelligence artificielle dans le but de filtrer, d’évaluer et/ou de sélectionner les candidats à ce poste.

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