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    Quality and Regulatory Affairs Specialist - Mississauga, ON, Canada - Juno Pharmaceuticals

    Juno Pharmaceuticals
    Juno Pharmaceuticals Mississauga, ON, Canada

    6 days ago

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    Description

    The Quality & Compliance Specialist jointly with the Manager, Quality is responsible for the quality assurance, quality control and quality compliance activities in support of the importation and distribution of JPC's drug products.

    The candidate will support the Manager, Quality in leading the operational oversight, decision making and performance of activities relating to establishment licensing, batch record review, product dispositions, vendor qualification, self-inspections, complaints, deviations, CAPAs, SOP writing, change control, process validation, analytical method validation/transfer, department KPI management, and the fulfilment of post market commitments.

    The Quality & Compliance Specialist must act as a positive influence toward quality awareness throughout the organization. The position requires detailed knowledge of Health Canada Food and Drugs Act, regulations and guidance documents.

    Experience in the quality and commercial requirements of sterile drug products used in a hospital setting for the provincial and territory health care programs in Canada is an asset.

    The role requires analytical thinking, evidence based decision making skills and exceptional time management abilities to progress multiple concurrent projects within established timelines.

    Support the digital transformation of the quality management system


    • Lead the enhancement and maintenance of training materials to provide effective SOP and GMP training to Juno's staff as needed.
    • Develop strategies to achieve method transfers and validations at Juno's local labs to facilitate product launches and confirmatory testing.
    • Perform dispositions of drug products to the Canadian market ensuring compliance to Health Canada regulations and Juno's SOPs.
    • Review Annual Product Quality Review and Yearly Biologic Product Reviews generated by Juno's quality assurance department and partners to ensure compliance to the marketing authorization.
    • Document, report, investigate and respond to product complaints.
    • Support the vendor qualification program by performing onsite, virtual and/or desk-based audits of JPC's GMP service providers.
    • Support the quality oversight of pharmaceutical manufacturing, packaging/labelling and testing deviations/non-conformance investigations and CAPA implementation at CMO's and internally.
    • Identify non-conformances, initiate investigations and lead the impact assessments to support process control and product dispositions.
    • Lead the maintenance of JPC's drug establishment licence foreign building annex, Table A and GMP evidence of foreign buildings.
    • Perform quality assurance impact assessment for internal and third-party related change control records.
    • Support in any regulatory or third party audit of JPC as required.
    • Proactively monitor USP and BP for monograph updates and prepare for implementation
    • Perform additional duties as assigned by the Manager, Quality.
    Post-Graduate Certification in Regulatory Affairs and Quality Assurance preferred.


    • Detailed knowledge of Canadian Food and Drugs Act and Regulations, Health Canada guidance documents, ICH guidance documents, GMPs and other relevant guideline with focus in sterile injectables used in a hospital setting.
    • Minimum 5 years relevant Canadian experience in a pharmaceutical quality assurance or compliance role with external audit experience.
    • Proactive with a high degree of self-discipline, drive and ability to work remotely or on-site with minimum supervision.
    • Excellent in Microsoft Office Suite and Adobe Acrobat.

    This job description for the Quality & Compliance Specialist outlines the primary responsibilities of the role and should not be considered a detailed description of all requirements that may be inherent in the job.

    The position is a hybrid position of remote work and in-office attendance with some domestic and international travel required to support the audit program as needed.

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