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    Senior Quality Assurance Specialist - Madrid, España - AbbVie

    AbbVie
    AbbVie Madrid, España

    hace 2 semanas

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    De jornada completa
    Descripción
    Job Description

    The Commercial Quality Specialist is responsible for providing Commercial Quality support in the affiliate. Scope of activities includes quality system requirements associated with pharmaceutical products, medical devices, combination products, biologics, and cosmetics. Specific areas of support may include Storage and Distribution, quality events/product shortage execution, Supplier Controls, Product Quality Review, Risk Management, Agency inspections/internal audits, CAPA, and overall Quality Manual requirements. The Sr. Specialist has in-depth knowledge of elements and is considered a subject matter expert in these areas. This position ensures that all product, process, or system related quality activities supporting the business at the affiliate are in compliance with regulations and requirements.

    The Technical Responsible person is the first contact for the Spanish Health Authorities and is accountable for oversight and all regulations pertaining to products on the market.

    Responsibilities:
    • Responsible for integrating local quality regulations.
    • Design effective quality systems, procedures, and processes within teams.
    • Work on assessments to determine compliance and identify potential gaps.
    • Plan, prepare, review, and approve quality documentation.
    • Support internal, external and MoH audits, lead self-inspections.
    • Coordinate and investigate quality events, deviations, non-conformances.
    • Execute supplier qualification program, monitor metrics and KPIs.
    • Support all activities governed by Good Storage and Distribution Practices.
    • Support the Management Review process for the affiliate.
    • Represent Commercial Quality in cross-functional teams, projects, and programs.
    • Host internal, external and MoH audits/inspections.
    • Technical Responsible of AbbVie Spain, responsibilities defined in current EU/local regulations.
    Qualifications
    • Bachelor's Degree in Pharmacy required.
    • 3+ years experience in quality assurance preferred.
    • Strong computer skills, familiarity with SAP, TrackWise, ComplianceWire, and OneVault.
    • Full understanding of local GxP requirements.
    • General knowledge of AbbVie MD, pharmaceutical, biologic, and cosmetic products.
    • Ability to support projects as a team member or lead.
    • Make decisions in collaboration with management.
    • Acts as an owner - uses available resources independently.
    • Influencing - Understand your stakeholders and shape communication.
    • Personal Presence - Demonstrate confidence that matches subject matter expertise.
    Additional Information

    AbbVie is committed to integrity, innovation, transforming lives, community service, and embracing diversity and inclusion. AbbVie's policy is to employ qualified individuals without discrimination based on various factors.

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