Specialist, Quality Assurance

Shoppers Drug Mart; Mississauga; On-site; CAD 70,000 - 90,000; Full time

Job summary

Shoppers Drug Mart is seeking a Specialist, Quality Assurance to ensure compliance with Good Manufacturing Practices and oversee quality systems management. This role involves documentation management, change control, and employee training. Candidates should have a Bachelor of Science degree and 3-5 years of experience in quality assurance within the pharmaceutical sector.

Benefits

Purchase discount program

Online learning opportunities

Competitive pay

Qualifications

• 3-5 years of experience in quality assurance in the pharmaceutical industry.
• Proficiency in Canadian GMPs and Medical Device Regulations.
• Ability to handle sensitive documentation and ensure timely resolutions.

Responsibilities

• Lead internal investigations and ensure compliance with Good Manufacturing Practices.
• Develop and implement plans for addressing compliance gaps.
• Conduct personnel training on GMP and Standard Operating Procedures.

Skills

Analytical Skills

Organizational Skills

Communication Skills

Problem-Solving

Education

Bachelor of Science degree or equivalent

Tools

SAP

Microsoft Office (Excel, Word, PowerPoint)

Job description

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

· Proficiency in SAP and all Microsoft Office applications (especially Excel , Word and PowerPoint)

· 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 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

· 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

· Act with pace and efficiency during investigations and ensure timely resolution of customer complaints, trends and non-conformances ensuring that root cause analysis and corrective/preventative actions are implemented.

. Ability to function & make decisions autonomously and in a team environment

. Result oriented, passionate about business needs

. Highly organized with a solid focus on detail and accuracy. Able to effectively prioritize and run multiple projects, tasks, and timelines.

Why work at Shoppers Drug Mart?

Acting as consultants, supporting internal customers and the Associate-Owners, you will get experience unique to the retail industry while working for an award-winning national brand. Benefit from a purchase discount program, competitive pay and online learning through Academy.

Take ownership of your work and find more ways to care about your work, co-workers, customers and community.

How You’ll Succeed:

At Shoppers Drug Mart Inc., we seek great people to continually strengthen our culture. We believe great people model our values, are authentic, build trust and make connections.

If that sounds like you, and you are open-minded, responsive to change and up to the challenges provided in a fast-paced retail environment, apply today.

Employment Type:

Full time

Type of Role:

Regular

Shoppers Drug Mart Inc. recognizes Canada's diversity as a source of national pride and strength. We have made it a priority to reflect our nation’s evolving diversity in the products we sell, the people we hire, and the culture we create in our organization. Accommodation is available upon request for applicants with disabilities in the recruitment and assessment process and when hired.

In addition, we believe that compliance with laws is about doing the right thing. Upholding the law is part of our Code of Conduct – it reinforces what our customers and stakeholders expect of us.

Please Note: If you have Employee Self Service (ESS) on Workday, apply to this job via the Workday application.

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