Specialist, Quality Assurance

Shoppers Drug Mart•Toronto, ON

23d•CA$60,000 - CA$82,500•Onsite

About The Position

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.

Requirements

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
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)

Responsibilities

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.
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.
Write and investigate CAPAs when non-conformances occur, utilizing Root Cause Analysis.
Ensure timely completion and closure of Non-conformances/Deviations/CAPA reports.
Update/Develop SOPs ensuring timely implementation.
Maintain and organize all quality documents.
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.
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.
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.
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.
Support the execution of the Validation Master Plan and validation protocols (e.g., process, equipment, facilities, software, material qualification) as required.
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.
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.
Support/Lead projects with quality/regulatory impact.
Determine and timely execute/implement quality requirements per plan.
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.