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    Qualified Person - Madrid, España - Inizio Engage

    Inizio Engage
    Inizio Engage Madrid, España

    hace 2 semanas

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    Descripción

    In Inizio Engage, we are recruiting for a direct and permanent position in a significant laboratory in Madrid, a Qualified Person & Quality Assurance (GDP activities) profile.

    What would be your main responsibilities?

    • Ensure local compliance with pharmaceutical regulations and legislation as the Qualified Person (QP), overseeing GDP achievements by the company and subcontractors.
    • Develop and maintain an effective Pharmaceutical Quality Management System (QMS) to align with EU GMP, GDP, GVP, and Corporate Quality Guidelines.
    • Collaborate with the Head of Affiliate to optimize departmental efficiency while ensuring compliance with relevant legislation.
    • Serve as the Responsible Person (RP) and RP (Import), personally fulfilling RP responsibilities.
    • Provide strategic input for business development, new product introductions, and local commercialization efforts.
    • Manage the workload, personal development of quality staff, and build relationships with local Regulatory Authorities.
    • Lead the implementation of the Country Quality system, ensuring safe, efficient, quality products and services across country organizations.
    • Develop and maintain a comprehensive understanding of EU GMP and GDP regulatory requirements.
    • Manage key quality processes, including the GMP and GDP Training Programme, Product Quality Complaints process, and Internal Audit Programme.
    • Communicate with the Supply Chain to implement the quality strategy, address compliance issues, and maintain uninterrupted product supply to the market.
    Número de vacantes: 1


    Modalidad de trabajo:
    Híbrido (50%)

    Tipo de contrato:
    Permanent contract

    Remuneración anual:
    Competitive fixed salary + bonus
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