Manager, Quality Assurance - Pharma

    Toronto, ON, Canada
    • Bachelor of Science in a science-related discipline
    • Knowledge of Canadian GMP’s and all relevant Health Canada Policies and Guidances
    • Minimum 5 years experience in the pharmaceutical industry within a QA capacity

    Kelly Scientific Resources (KSR) is a specialty service of Kelly Services, Inc., a leader in providing workforce solutions.  Since its launch in 1995, KSR has provided staffing and placement services to a broad spectrum of industries, including biotechnology, chemical, consumer products, cosmetics, environmental, food sciences, medical/clinical, pharmaceutical, and petrochemical.  Today, KSR leads the world in dedicated scientific and clinical research staffing.  Visit www.kellyscientific.com to learn more and view a full listing of our opportunities.

    MANAGER, QUALITY ASSURANCE - Pharma

    REQUIREMENTS:

    • Knowledge of Canadian GMP’s and all relevant Health Canada Policies and Guidances.
    • Bachelor of Science in a science-related discipline. Post graduate training in Pharmaceutical Quality Studies an asset.
    • Minimum 5 years experience in the pharmaceutical industry within a QA and supervisory capacity.
    • 2+ years of QA product release experience.
    • Ability to coordinate and manage multiple projects simultaneously.
    • Ability to work independently and make decisions based on judgment and integrity.
    • Ability to work in a fast-paced environment.
    • Good interpersonal skills; ability to interact with staff, clients and key stakeholders on all levels.
    • Experience with Inventory Management system.
       

    RESPONSIBILITIES:

    • Responsible for writing, reviewing, and revising SOPs and quality policies ensuring GMP, regulatory and customer requirements are met.
    • Responsible for the release of finished products to market - ensuring that all GMP documentation is correct and compliant.
    • Coordinating, tracking, and approving method transfers and finished product testing with the contract laboratory.
    • Assisting with recall of any defective products.
    • Coordinate with Warehouse staff for incoming product inspection and label review.
    • Maintaining retain sample inventory for all products.
    • Communicate documentation and release issues, including delays in receiving documentation from Contract Fabricators, deviation investigations, corrective and preventative actions, out of specification investigations, etc.
    • Review of Executed Batch Records.
    • Collect and/or review technical records for method and process validation protocols and reports.
    • Tracking stability for commercial and submission lots on an ongoing basis and ensuring stability for products to support shelf life is filed.
    • Working with 3rd party and foreign site organizations on GMP matters to resolve quality matters as require and/or meet Canadian GMP requirements
    • Responsible for the GMP and SOP Training of all staff members and warehouse personnel.
    • Responsible for the tracking, review, investigation and resolution of product complaints.
    • Responsible for the approval of change controls and verifying all Post-NOC and quality requirements are met.
    • Responsible for approval of contract fabricator change controls in coordination with regulatory affairs and ensuring all post-NOC requirements are met.
    • Responsible for approval of master production documents.
    • Review of Annual Product Quality Reports (APQRs) to verify alignment of changes on record.

     

     


    Category: Biotechnology & Pharmaceutical

    Reference ID: CA7677BM001396

    Date Posted: 03/07/2019

    Shortcut: http://jobs.en.kellyservices.ca/NjLxme

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