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    Quality Assurance Specialist - United Kingdom - Galderma Pharma S.A

    Galderma Pharma S.A
    Galderma Pharma S.A United Kingdom

    2 weeks ago

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    Description
    Senoir Quality Assurance Specialist page is loaded Senoir Quality Assurance Specialist

    Apply locations Thornhill posted on Posted 3 Days Ago job requisition id JR007887 With a unique legacy in dermatology as well as decades of cutting-edge innovation, Galderma is the pure-play dermatology category leader, present in approximately 90 countries.

    We deliver an innovative, science-based portfolio of premium flagship brands and services that spans the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermo-cosmetics, and Therapeutic Dermatology.

    Since our foundation in 1981, we have dedicated our focus and passion to the human body's largest organ – the skin – meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals.

    Across our company, we embrace diversity and respect the dignity, privacy, and personal rights of every employee.

    At Galderma, we actively give our teams reasons to believe in our bold ambition to become the leading dermatology company in the world.

    With us, you have the ultimate opportunity to gain new and challenging work experiences and create an unparalleled, direct impact.


    Job Title:
    Senior Quality Assurance Specialist

    The Senior Quality Assurance Specialist is responsible to ensure that imported and distributed products by the Company meet the expectations and requirements of global and local policies and Health Canada regulations.

    The Senior Quality Assurance Specialist works independently and provide direction to other QA team member to assist with all aspect of (cGMPs) including batch record review, batch disposition, new product introduction and supplier/ vendor management.

    Quality oversight responsibilities include ensuring adherence to SOPs and requirements, proper change control, corrective action and preventive action plans (CAPA) management, assessments for changes to processes, risk management, ensuring documentation and investigations meet all requirements.

    Provide training to QA specialists as needed.

    Lead and train others in market releases of batches of drug, NPN, medical devices and cosmetic products for the Canadian Market.

    Management of GMP compliance issues with manufacturing sites, contract packagers, warehouse and contract laboratories, shipping and storage conditions.

    Establishment Licenses:
    Responsible in maintaining various site licenses with regards to DIN, Medical Device and NPN products.

    Review of GMP related documents, such as transportations, Annual Product Quality Review (APQR), Yearly Biologic Product Report (YBPR), on-going stability data, validation documents and master batch records.

    APQR - Write Market APQR and collaborate with Regulatory team in completion of the report.
    Quality Documentation
    Review and approve test reports and out of specifications from contract laboratories.
    Provide guidance to contract laboratory for any out of specification procedure and reports.
    Complaint - Provide guidance complaint investigations, troubleshooting, general issues, and trending to identify areas for improvement and CAPA.

    Audit – Encompasses in readiness activities related to internal, regulatory agencies and notified body inspect and conduct periodic Internal audit.

    Assist QA manager to underwrite to KPIs associated with aspects of QMS activities.

    Vendors/ supplier management - Assist QA manager in the identification, approval/ qualification, and ongoing maintenance of vendors or suppliers.

    Bachelor's degree required (Engineering or Sciences).

    5 to 7 years of related experience in Quality Assurance within a pharmaceutical and Medical Device industries with at least 2 years' experience with emphasis in Importation and Distribution of pharmaceuticals, Medical Device and NHP products.

    Understanding of pharmaceutical manufacturing and laboratory processes.
    In depth knowledge of applicable Health Canada and global pharmaceutical regulations (e.g. Basic MS Office computer and software proficiency
    Experience in pharmaceutical manufacturing and/or laboratory environment is a strong asset.
    Pension program after one year of service (company contribution of up to 10%)
    Tuition Reimbursements
    If your profile is a match, we will invite you for a first virtual conversation with the recruiter.
    The next step is a virtual conversation with the hiring manager

    Professionalism, collaboration, and a friendly, supportive ethos is the perfect environment for people to thrive and excel in what they do.

    Galderma is the world's largest independent dermatology company, present in approximately 100 countries. Since our inception in 1981, we have been driven by a complete dedication to dermatology. We deliver an innovative, science-based portfolio of sophisticated brands and services across Aesthetics, Consumer Care and Prescription Medicine.
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