Senior Specialist, Quality Assurance

Shoppers Drug Mart•Toronto, ON

39d•CA$68,000 - CA$93,500•Onsite

About The Position

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 Director, Quality Assurance, the incumbent will be responsible for implementing and maintaining the enterprise Quality Systems and supporting the distribution centers ensuring compliance with Canadian laws and Health Canada regulations and guidelines applicable to drugs, medical devices and natural health products. This includes reviewing documents, evaluating returned products, providing product disposition, developing SOPs, risk assessment and management, auditing, validation, change control, non-conformances, CAPAs, maintaining regulatory licenses, etc.

Requirements

Minimum 3 years working in GMP pharmaceutical industry in Quality Assurance
Must have a Bachelor of Science (or Canadian Equivalent)
Solid experience in writing and conducting validation protocols
Strong understanding of Health Canada GMP and other related guidelines, 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
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.
Advanced 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
Sound knowledge of compliance and regulatory components, auditing skills, and quality systems
Interpret Health Canada GMPs and other Guidelines and regulations, 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
Computer skills to produce effective reports, documents, spreadsheets and presentations.
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 SAP and all Microsoft Office applications (especially Excel , Word and PowerPoint)

Nice To Haves

Preferred – Bachelor of Science in Pharmacy
Regulatory Affairs, Supply Chain and Logistics experience, an asset

Responsibilities

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
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
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
Conduct internal and external audits, prepare report and follow-up on issues identified ensuring timely and 100% completion of corrective/preventive actions
Internal GMP Self Inspection: Audit and report on the GMP management system to ensure its on-going effective application
Support Regulatory (e.g. Health Canada) inspections with the Sr. Manager QA and Sr. Director QA
Track closure of audit commitments
Track and timely 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
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
Evaluate returned products and associated documentation and provide product disposition
Write and execute Validation Master Plan and validation protocols (e.g. process, equipment, facilities, software qualification, material qualification, etc.)
Analyze validation results and write validation final reports
Review validation protocols and reports
Follow-up on completion of validation/re-validation
Conduct seasonal transport lane temperature profile studies
Conduct personnel training on GMPs and SOPs
Track timely completion of personnel training and manage personnel quality training records
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
Support development and execution of FCA/Recalls
Provide Recall report to supplier, as required
Prepare quarterly and annual reports on quality metrics
Maintain establishment licenses issued by Health Canada
Support/Lead projects with quality/regulatory impact
Determine and timely execute/implement quality requirements per plan
Support of other Healthcare businesses, as required
Perform other Quality duties, as assigned
Occasional travel to various SDM/vendor sites is required