Specialist, Quality Assurance

at  Sanis

Referred applicants must not apply directly to this role. All referred applicants must use their unique referral link generated when they are referred by an existing colleague.

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 1-3 years working experience in GMP pharmaceutical industry in Quality Assurance
• Must have a Bachelor of Science (or Canadian Equivalent)
• Understanding of Health Canada GMP and other related guidelines, Medical Device Regulations, Natural Health Product Regulations, the Narcotic Controlled Regulations, Controlled Drugs and Substances Act, Benzodiazepine and Other Targeted Substances Regulations, Precursor Control Regulations, Cannabis Regulations

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.
• 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
• Knowledge of compliance and regulatory components, auditing skills, and quality systems
• Interpret Health Canada GMPs and other Guidelines and regulations, 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
• 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
• Able to work with minimal supervision.
• Proficiency in SAP and all Microsoft Office applications (especially Excel, Word and PowerPoint)

DUTIES AND RESPONSIBILITIES:

Working closely within the enterprise Operations, product category teams, and external suppliers, the Specialist Quality Assurance will deliver the development, implementation and maintenance of quality systems and standards.

• 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 and timely periodic review
• Maintain organization of all quality documents and records
• Regulatory and Compliance:
• Review and process change requests for product create/listing/de-listing
• Perform compliance audit of health product postings on eCommerce websites
• Obtain and review health product labels ensuring compliance with the current regulations. For medical devices, determine and maintain a list of medical device manufacturer’s name and address
• Review and provide quality and regulatory impact assessment on process/equipment/supplier/product label and license/material change requests
• Support the maintenance of establishment licenses issued by Health Canada
• Update metrics
• Non-conformances/Deviations/CAPAs:
• Conduct or support the investigation of non-conformances/deviations/CAPAs ensuring timely completion and closure of records
• Support the review and assessment of complaints, temperature excursions and liaise between suppliers and distribution centers in obtaining product stability information / assessment from suppliers and issuing product disposition, as needed
• Write CAPAs when non-conformances occur
• Review, track and trend deviations/non-conformances/CAPAs
• Internal/External Quality/Regulatory Audits
• Support Regulatory (e.g. Health Canada) inspections and internal audits
• Track closure of audit commitments
• Supplier Quality
• Support supplier and/or material qualification (e.g. supplier audits, establishment of Quality Agreements, product review/assessment)
• Obtain and maintain copies of current suppliers’ regulatory licenses (i.e. DEL, MDEL, Site License, Narcotic, Precursor, Authorized Personnel) annually
• Returned Products
• Evaluate returned products and associated documentations and provide product disposition
• Personnel Training
• Conduct personnel training on GMPs and SOPs, as needed
• Track timely completion of personnel training and manage personnel quality training records
• Management Review Meetings
• Report on the status of SDMI and distribution center Quality Systems to QA management
• Prepare semi-annual and annual reports on quality goals and metrics
• Present and participate in the quality management review meetings
• Holds/Recalls:
• Support development and execution of Holds/Recalls
• Provide Holds/Recall report to supplier, as required
• Prepare s- reports on quality metrics on specified frequency
• Project Management
• Support projects with quality/regulatory impact
• Determine and timely execute/implement quality requirements per plan
• Others:
• Support of other Healthcare businesses, as required
• Perform other Quality duties, as assigned
• Occasional travel to various SDM/vendor sites, as required

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.

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 1-3 years working experience in GMP pharmaceutical industry in Quality Assurance
• Must have a Bachelor of Science (or Canadian Equivalent)
• Understanding of Health Canada GMP and other related guidelines, Medical Device Regulations, Natural Health Product Regulations, the Narcotic Controlled Regulations, Controlled Drugs and Substances Act, Benzodiazepine and Other Targeted Substances Regulations, Precursor Control Regulations, Cannabis Regulation