Senior Specialist, Quality Assurance

Location:
243 Consumers Road, Toronto, Ontario, M2J 4W8

Why this role is important?

Senior Specialist, Quality Assurance

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:

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, 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.

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

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

Hiring Range / Échelle salariale à l'embauche :

$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.

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