Senior Specialist, Quality Assurance

Shoppers Drug Mart•Toronto, ON

2d•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 to the Director, Quality Assurance, this role supports quality assurance activities at Sanis. The Sr. Quality Assurance Specialist will ensure that all pharmaceutical manufacturing, testing, product release, distribution and post market surveillance activities of third party manufactured products are carried out in compliance with Good Manufacturing Practices (GMP), Health Canada regulations, and other applicable corporate standards and procedures.

Requirements

Able to work with minimal of supervision and rutilizes 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 environment.
Sound knowledge of compliance and regulatory components, auditing skills, and quality systems.
Communicates with clarity, both verbally (in one on one or group situations) and in writing by composing clear email communication, documents and/or presentations.
Proof-reading is required of manufacturing documentation and test results.
Computer skills to produce effective reports, documents, spreadsheets, and presentations.
Proficiency with Microsoft Office applications (Outlook, Excel, Word, PowerPoint, Teams), ERP systems (SAP) and electronic QMS Systems (TrackWise, Veeva, ZenQMS, etc).
Minimum of 5 years’ experience in a quality role in a pharma company, preferably in quality assurance in a pharma manufacturing environment.
Self-motivated; highly organized with the ability to work in a fast-paced environment.
Good technical writing skills.
Strong interpersonal and communication skills to initiate necessary actions with third party organizations and internal stakeholders.
Good communication skills (both written and verbal)
Project management experience and / or ability.

Nice To Haves

Completion of a post-graduate diploma in pharmaceutical regulatory affairs or quality assurance would be an asset.
Bilingual in French would be an asset.
Experience with regulatory drug submissions an asset.

Responsibilities

Responsible for finished goods product releases and ensuring that batch production records are complete, accurate and in compliance
Actively manage and maintain third party documentation in Product Master Files (PMF’s) and ensure PMF’s are kept up to date on an ongoing basis.
Reviews and assess vendor deviations, CAPAs and change controls
Assist in reviewing and writing SOPs according to GMP requirements
Actively support Sanis Quality Assurance Systems relating to training, deviations, product complaint, product recalls, CAPA’s, stability, annual product requirements and change controls
Review annual product quality reports (APQR’s)
Support vendor compliance inspection or audits
Support Director, Quality Assurance as required in the implementation of projects to improve processes and procedures and reduce operating costs.
Support Manager, Regulatory Affairs as required for labelling review and update and provincial submission documentation preparation and filing.
Participate on project teams as required.