Specialist, Quality Assurance

**Location**:
1685 Tech Ave, Mississauga, Ontario, L4W 0A7

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?**

The **Specialist, Quality Assurance**is responsible for ensuring quality systems work properly and in compliance with Good Manufacturing Practices (GMP) and Canadian Medical Device Regulations. This role will lead internal investigations, liaise with customers when required, make product release decisions, and develop and maintain tracking and trending reports for Quality Systems.

**What you will do**:
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:

- Review and provide quality and regulatory impact assessment for proposed changes
- Review and process change requests for product listing, and review medical device labeling for listing and distribution of product

Non-conformances/Deviations/CAPAs:

- Support investigation of deviations and participate in decision-making/product disposition for quality issues
- Review and ensure timely completion and closure of Non-conformances/ Deviations/CAPAs reports
- Facilitate timely approval and closure of investigation records by performing follow-up activities and correspondence with required personnel
- Review, track and trend deviations/non-conformances/CAPAs in eQMS and distribute as required

Returned Products:

- Evaluate returned products and associated documentation and provide product disposition.

Product Complaints:

- Track and report product complaints to suppliers and follow-up on corrections/corrective actions, as needed
- Facilitate timely approval and closure of complaints
- Liaise effective processing of complaints and return of complaint samples to suppliers, as needed

Training:

- Conduct personnel training on GMP and SOPs
- Track timely completion of personnel training and manage personnel quality training records

Recalls:

- Support development and execution of Recalls

Other:

- Support with the review and evaluation (as required) of GMP documentation related to preventative maintenance, temperature monitoring, pest control and cleaning and sanitation
- Liaise with co-workers to identify and implement Quality Improvement initiatives
- Prepare quarterly and annual reports on quality goals and metrics
- Present and participate in the quality management review meetings
- Participate in audits, audit response, and closing of resulting CAPAs
- Support qualification activities for service providers
- Other Quality duties, as assigned

**What you will need**:

- Must have a Bachelor of Science degree or equivalent
- Three (3) to five (5) years of experience in quality assurance in the pharmaceutical industry
- Proficient knowledge of Canadian GMPs and other related guidelines, and Medical Device Regulations
- Organizational skills and ability to manage several projects or tasks at once; results oriented
- Thoroughness and concern for a job well done.
- Excellent analytical skills and ability to focus.
- Excellent oral and written communication skills in English.
- Team spirit, open-mindedness and ability to communicate effectively with tact and diplomacy.

Additional Skills and Experience:

- 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
- Maintaining quality and patient safety first while recognizing the importance of good business decisions
- Computer skills to produce ef