Quality Assurance Officer - Barcelona - Ergomed

    Ergomed
    Ergomed Barcelona

    hace 4 días

    Descripción
    Company Description

    Consulte la descripción del puesto a continuación. Si confía en que tiene las habilidades y la experiencia adecuadas, envíe su solicitud hoy mismo.
    We are PrimeVigilance (part of Ergomed Group), a specialised mid-size pharmacovigilance service provider established in 2008.

    We are proud to have achieved global organic growth year after year, with staff based across Europe, North America and Asia all covering services within:
    Medical Information, Pharmacovigilance, Regulatory Affairs and Quality Assurance.


    PrimeVigilance provides first class support to our small to large pharmaceutical and biotechnology partners maintaining long lasting relationships and has become one of the global leaders in its field.

    We cover all therapy areas including medical device.

    We love investing in our staff by providing an excellent training and development platform.

    We value employee experience, well-being and mental health and we acknowledge that a healthy work life balance is a critical factor for employee satisfaction and in turn nurtures an environment from which a high-quality client service can be achieved.

    Come and join us in this exciting journey to make a positive impact in patient's lives.

    Job Description
    Role and Responsibilities


    The Quality Officer will support all audit activities within PrimeVigilance and will work with the Auditing team and Quality team s to ensure audits are delivered in line with PrimeVigilance and procedures and global regulations.

    The Quality Officer will perform all activities described, including but not limited to:

    Audit Support

    Supports PrimeVigilance functional teams during the pre-audit, audit, and post-audit stages for audits by clients or by PrimeVigilance internal QA function

    Hosts onsite and remote audits

    Provides support for regulatory inspections of clients

    Assists in scheduling client requests for audits/inspection support

    Administrative support

    Supports Quality in the tracking of audit status and deliverables

    Metrics and Key Performance Indicators

    Supports Quality in the compilation and reporting of metrics and KPIs

    Collects and collates data from systems and sources

    Authors reports and summaries

    CAPA Support Activities

    Supports Quality in the tracking of Deviations and CAPAs

    Facilitates CAPA response and resolution

    Inputs data into the global audit CAPA tracker

    Other Supportive Responsibilities

    Supports Controlled Document preparation by reviewing draft documents, e.g., SOPs, OGs

    Supports the PrimeVigilance Senior Leadership team as needed.

    Supports other Quality activities as needed.

    Qualifications


    University degree in Biomedical sciences, Natural sciences or Health Sciences is required: Nursing, Pharmacy or BS/Master's degree in a scientific discipline, or equivalent advanced degree with pharmaceutical industry experience.

    Or equivalent pharmaceutical industry experience.

    Previous experience in the pharmaceutical and/or regulated industry in a quality setting – preferably in Pharmaceuticals or Healthcare

    Thorough understanding of the principles of Quality Assurance

    Knowledge of national regulations and guidance related to Pharmacovigilance and Medical Information

    Experience of participating in audits and inspections

    Excellent communication and facilitation skills within a global organisation

    Proactive and self-motivated

    Additional Information

    We prioritize diversity, equity, and inclusion by creating an equal opportunities workplace and a human-centric environment where people of all cultural backgrounds, genders and ages can contribute and grow.

    To succeed we must work together with a human first approach.

    Why? because our people are our greatest strength leading to our continued success on improving the lives of those around us.


    We offer:
    Training and career development opportunities internally

    Strong emphasis on personal and professional growth

    Friendly, supportive working environment

    Opportunity to work with colleagues based all over the world, with English as the company language

    Our core values are key to how we operate, and if you feel they resonate with you then PrimeVigilance could be a great company to join xugodme

    Quality

    Integrity & Trust

    Drive & Passion

    Agility & Responsiveness

    Belonging

    Collaborative Partnerships

    We look forward to welcoming your application.

    #J-18808-Ljbffr

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