243 Consumers Road, Toronto, Ontario, M2J 4W8
Take ownership and find more ways to care about our local store owners in a career at Shoppers Drug Mart Central Office / Store Support. Provide great service, specific expertise and actionable advice to support Associate-Owners and their staff in delivering the best health, beauty and convenience services to Canadians.
Why this role is important?
Reporting directly to the Manager, Quality Assurance, the incumbent will be responsible for implementing and maintaining quality and regulatory compliance with Canadian laws, Health Canada and Pharmacy regulations. This role will be responsible for maintaining the GXP computerized systems state of validation and other critical systems validation.
Duties and Responsibilities:
Working closely within the various departments, distribution centres 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.
Write/Review CAPAs when non-conformances occur
Provide support by reviewing and ensuring timely completion and closure of Non-conformances/ Deviations/CAPAs 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 with the Sr. Manager QA and Sr. Director QA
Track closure of audit commitments
Support supplier and/or material qualification (e.g. vendor audits)
Management Review Meetings
Report on the status of Quality Systems to Manager, Quality Assurance
Prepare quarterly and annual reports on quality goals and metrics
Present and participate in the quality management review meetings
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
Support of other Healthcare businesses, as required
Perform other Quality duties, as assigned
Occasional travel to various SDM/vendor sites is required
Skills and Experience:
This position requires a high level of initiative and judgment in order to organize and prioritize tasks, workload and projects. A strong ability to influence while maintaining courtesy, tact and diplomacy is required in dealing with colleagues in every day working relationships.
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, 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)
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 SDMU.
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.
Type of Role:
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.