Specialist, Quality Assurance - Toronto, Canada - Sanis

Sanis

Verified Company

Toronto, Canada

2 weeks ago

Posted by:

Sophia Lee

beBee Recruiter

Description

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/delisting
Review and provide quality and regulatory impact assessment on process/equipment/supplier/ material change requests from SDM Operations and distribution centers
Update metrics
Nonconformances/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 nonconformances occur
Provide support by reviewing and ensuring timely completion and closure of Nonconformances/ Deviations/CAPAs reports
Review, track and trend deviations/nonconformances/CAPAs
Internal/External Quality/Regulatory Audits
Participate in conducting internal and external audits, preparing reports and followup 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 followup 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