Location:
243 Consumers Road, Toronto, Ontario, M2J 4W8
Why this role is important?
Why is this role important:
Reporting directly to Director, Quality Assurance, the incumbent will be responsible for implementing and maintaining the enterprise Quality Systems and supporting the distribution centers ensuring compliance with Canadian laws and Health Canada regulations and guidelines applicable to drugs, medical devices and natural health products. This includes reviewing documents, evaluating returned products, providing product disposition, developing SOPs, risk assessment and management, auditing, validation, change control, non-conformances, CAPAs, maintaining regulatory licenses, etc.
What you'll do:
Working closely within the enterprise Operations and with external suppliers, the Sr. Specialist Quality Assurance will deliver the development, implementation and maintenance of quality systems and standards.
• Document/Record Management:
o Review government, regulatory and corporate policies to ensure all procedures are current and meet requirements
o Identify compliance gaps, develop and implement plans to address compliance gaps
o Update/Develop SOPs ensuring timely implementation
o Maintain organization of all quality documents
• Change Control (Internal and External)
o Review and process change requests for product create/listing/de-listing
o Review and provide quality and regulatory impact assessment on process/equipment/supplier/ material change requests from SDM Operations and distribution centers
o Update metrics
• Non-conformances/Deviations/CAPAs:
o Support the oversight of Product Quarantine/Reject process at Distribution Centers
o Liaise between suppliers and distribution centers in obtaining product stability information/ assessment from suppliers and issuing product disposition to distribution center QA in the event of temperature excursion impacting/potentially impacting products
o Write CAPAs when non-conformances occur
o Provide support by reviewing and ensuring timely completion and closure of Non-conformances/ Deviations/CAPAs reports
o Review, track and trend deviations/non-conformances/CAPAs
• Internal/External Quality/Regulatory Audits
o Conduct internal and external audits, prepare report and follow-up on issues identified ensuring timely and 100% completion of corrective/preventive actions
o Internal GMP Self Inspection: Audit and report on the GMP management system to ensure its on-going effective application
o Support Regulatory (e.g. Health Canada) inspections with the Sr. Manager QA and Sr. Director QA
o Track closure of audit commitments
• Product Complaints:
o Track and timely report product complaints to suppliers and follow-up on corrections/corrective actions, as needed
o Liaise effective processing of complaints and return of complaint samples to suppliers, as needed
o Communicate corrections/corrective actions by supplier internally and to distribution center QA, as needed
• Supplier Quality
o Support supplier and/or material qualification (e.g. vendor audits, establishment of Quality Agreements, product review/assessment)
o Maintain copies of current suppliers' regulatory licenses (i.e. DEL, MDEL, Narcotic, Precursor, Authorized Personnel) - annual
• Returned Products
o Evaluate returned products and associated documentation and provide product disposition
• Validation/Qualification:
o Write and execute Validation Master Plan and validation protocols (e.g. process, equipment, facilities, software qualification, material qualification, etc.)
o Analyze validation results and write validation final reports
o Review validation protocols and reports
o Follow-up on completion of validation/re-validation
o Conduct seasonal transport lane temperature profile studies
• Personnel Training
o Conduct personnel training on GMPs and SOPs
o Track timely completion of personnel training and manage personnel quality training records
• Management Review Meetings
o Report on the status of SDM and distribution center Quality Systems to Sr. Manager, QA
o Prepare quarterly and annual reports on quality goals and metrics
o Present and participate in the quality management review meetings
• FCA/Recalls:
o Support development and execution of FCA/Recalls
o Provide Recall report to supplier, as required
o Prepare quarterly and annual reports on quality metrics
• Regulatory Affairs:
o Maintain establishment licenses issued by Health Canada
• Project Management
o Support/Lead projects with quality/regulatory impact
o Determine and timely execute/implement quality requirements per plan
• Others:
o Support of other Healthcare businesses, as required
o Perform other Quality duties, as assigned
o Occasional travel to various SDM/vendor sites is required
What you bring:
This position requires an advanced 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 everyday working relationships.
• Minimum 3 years working in GMP pharmaceutical industry in Quality Assurance
• Must have a Bachelor of Science (or Canadian Equivalent); Preferred - Bachelor of Science in Pharmacy
• Solid experience in writing and conducting validation protocols
• Strong 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
• Regulatory Affairs, Supply Chain and Logistics experience, an asset
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
• 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
• 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 of supervision.
• Proficiency in SAP and all Microsoft Office applications (especially Excel , Word and PowerPoint)
Employment Type:
Full time
Type of Role:
Regular
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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