Senior Specialist, Quality Assurance

Loblaw; Toronto; On-site; CAD 68,000 - 94,000; Full time

Benefits offered by this job

Purchase discount program

Online learning through Academy

Job summary

Shoppers Drug Mart Inc. is seeking a Senior Specialist, Quality Assurance to implement and maintain quality and regulatory compliance with Canadian laws, Health Canada and Pharmacy regulations.

The role requires coordinating audits, CAPAs and validation activities across departments and suppliers, while ensuring GxP adherence. Travel to SDM/vendor sites may be required, and a strong quality mindset is essential for patient safety and operational excellence.

Qualifications

• Minimum 5-year working experience in GMP pharmaceutical industry in Quality Assurance.
• Bachelor of Science or Canadian equivalent is required.
• Knowledge of CSV/GAMP, 21 CFR Part 11, Annex 11, GMP, project life cycle and quality systems.

Responsibilities

• Develop, implement, and maintain quality systems per Health Canada and GMP standards.
• Lead validation lifecycle activities (IQ/OQ/PQ) for new and existing systems.
• Perform internal GMP self-inspections and support regulatory inspections.
• Review and close non-conformances, deviations, and CAPAs.
• Prepare reports and summarize quality metrics for management.

Skills

GMP QA

Regulatory compliance

GxP knowledge

Documentation

Education

Bachelor of Science

Tools

CSV/GAMP

21 CFR Part 11

Annex 11

Job description

Location

243 Consumers Road, Toronto, Ontario, M2J 4W8

Senior Specialist, Quality Assurance

Why this role is important?

Reporting directly to the Director, Quality Assurance, the incumbent will be responsible for implementing and maintaining quality and regulatory compliance with Canadian laws, Health Canada and Pharmacy regulations.

Duties And Responsibilities

Working closely within the various departments, distribution centers and external suppliers, the Sr. Specialist Quality Assurance will deliver the following:

• Provide support in the establishment, implementation and maintenance of quality systems including:
  • Applying GMP guidelines to all aspects of validation.
  • Maintain GxP computerized systems state of validation by ensuring: projects, enhancements, and fixes are all documented to Health Canada standards.
  • Act as the validation subject matter expert, authoring and owning processes and policies relating to GxP validation.
  • Review validation plans, user requirements specifications (URS) and change management proposals.
  • Reviews / Authors Validation Master Plans for compliance with regulatory requirements.
  • Authoring and reviewing validation summary reports following good documentation practices
  • Oversight over the SSI automation changes within the distribution centers, monitoring the SSI-Schaeffer Portal in terms of compliance changes requiring validation and ensuring the systems are maintained in a validated state.
  • Responsible for change management through change control for computerized systems validation.
  • Working with project teams to define the regulatory requirements, assign actions, and follow through of execution for validation
  • Responsible for preparing and executing validation documentation (IQ/OQ/PQ) for validation of new and existing systems
  • For GxP impacting systems, providing guidance in all phases of the validation lifecycle, from design, commissioning, SATs, qualification, and maintenance.
  • Investigation through root cause analysis any deviations and non-conformances.
  • Support other validation activities as required such as temperature mapping, facility systems validation, lane profiling, generator, BAS, etc.
• Non-conformances/Deviations/CAPAs:
  • Write/Review CAPAs when non-conformances occur
  • Provide support by reviewing and ensuring timely completion and closure of non-conformances/deviations/CAPA reports
  • Review, track and trend deviations/non-conformances/CAPAs
• Internal/External Quality/Regulatory Audits:
  • Internal GMP Self Inspection: Audit and report on the GMP management system to ensure its on-going effective application
  • Perform audit (as needed) and follow-up on issues identified ensuring timely and 100% completion of corrective/preventive actions
  • Support Regulatory (e.g. Health Canada) inspections
  • Track closure of audit commitments
• Supplier Quality:
  • Support supplier and/or material qualification (e.g. vendor audits)
• Management Review Meetings:
  • Report on the status of Quality Systems
  • Prepare semi-annual and annual reports on quality goals and metrics
  • Present and participate in the quality management review meetings
• 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 related quality documents
• Others:
  • Support of other Healthcare businesses and projects as required
  • Perform other Quality duties, as assigned
  • Occasional travel to various SDM/vendor sites is required

Skills And Experience

• Minimum 5-year working experience in GMP pharmaceutical industry in Quality Assurance
• Must have a Bachelor of Science (or Canadian Equivalent)
• Knowledge of CSV/GAMP, 21 CFR Part 11, Annex 11, GMP, project life cycle and quality systems.

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.
• 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
• 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
• 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)

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.

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.

Employment Type

Full time

Type Of Role

Regular

Diversity and Inclusion

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.

Salary

$68,000.00 - $93,500.00 / 68.000,00$ - 93.500,00$ (per year / par an)

A candidate’s experience and knowledge as well as the geographical region in which the position is located may be factored into the pay a candidate receives for this position. This posting is for an existing vacancy. The Company uses artificial intelligence for the purpose of screening, assessing and/or selecting applicants for this position. / L’expérience et les connaissances d’un candidat ainsi que la région géographique dans laquelle le poste est situé peuvent être prises en compte dans la rémunération qu’un candidat reçoit pour ce poste. Cette offre d’emploi concerne un poste vacant existant. L’entreprise utilise l’intelligence artificielle dans le but de filtrer, d’évaluer et/ou de sélectionner les candidats à ce poste.