Specialist, Quality Assurance

7 months ago

Toronto, Canada Sanis 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?**

**Specialist, Quality Assurance**

Reporting directly to the Senior 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 distribution businesses involving drugs, medical devices and natural health products.

**Duties and Responsibilities**:
Working closely within the enterprise Operations and external suppliers, the Specialist Quality Assurance will deliver the development, implementation and maintenance of quality systems and standards.
- Document/Record Management:

- Review 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 organization of all quality documents
- Change Control (Internal and External)
- Review and process change requests for product create/listing/de-listing
- Review and provide quality and regulatory impact assessment on process/equipment/supplier/ material change requests from SDM Operations and distribution centers
- Update metrics
- Non-conformances/Deviations/CAPAs:

- Support the oversight of Product Quarantine/Reject process at Distribution Centers
- 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
- Write CAPAs when non-conformances occur
- Provide support by reviewing and ensuring timely completion and closure of Non-conformances/ Deviations/CAPAs reports
- Review, track and trend deviations/non-conformances/CAPAs
- Internal/External Quality/Regulatory Audits
- Participate in conducting internal and external audits, preparing reports and follow-up on issues identified ensuring timely and 100% completion of corrective/preventive actions
- Support Regulatory (e.g. Health Canada) inspections with the Sr. Manager QA, Director QA and Sr. Director QA
- Track closure of audit commitments
- Product Complaints:

- Track and report product complaints to suppliers and follow-up on corrections/corrective actions, as needed
- Liaise effective processing of complaints and return of complaint samples to suppliers, as needed
- Communicate corrections/corrective actions by supplier internally and to distribution center QA, as needed
- Supplier Quality
- Support supplier and/or material qualification (e.g. vendor audits, establishment of Quality Agreements, product review/assessment)
- Maintain copies of current suppliers’ regulatory licenses (i.e. DEL, MDEL, Narcotic, Precursor, Authorized Personnel) - annual
- Returned Products
- Evaluate returned products and associated documentations and provide product disposition
- Validation/Qualification:

- Support the writing and execution of the Validation Master Plan and validation protocols (e.g. process, equipment, facilities, software qualification, material qualification, etc.)
- Support the analysis of validation results and write validation final reports
- Personnel Training
- Conduct personnel training on GMPs and SOPs
- Track timely completion of personnel training and manage personnel quality training records
- Management Review Meetings
- Report on the status of SDM and distribution center Quality Systems to Sr. Manager, QA
- Prepare quarterly and annual reports on quality goals and metrics
- Present and participate in the quality management review meetings
- Field Corrective Action (FCA)/Recalls:

- Support development and execution of FCA/Recalls
- Provide Recall report to supplier, as required
- Prepare quarterly and annual reports on quality metrics
- Regulatory Affairs:

- Support the maintenance of establishment licenses issued by Health Canada
- Project Management
- Support projects with quality/regulatory impact
- Determine and timely execute/implement quality requirements per plan
- Others:

- Support of other Healthcare businesses, as required
- Perform other Quality duties, as assigned
- Occasional travel to various SDM/vendor sites is required

**Skills and Experience**:
This position requires a high leve

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