Tipo di lavoro: Freelance

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Contenuto del lavoro

Interested ? Don’t hesitate to contact me and take a look at the job description below !

megane.libert@professionals.randstad.be

    qualifications

    • former relevant industrial experience related to the requested seniority in validation and qa in a biopharmaceutical industry
    • knowledge of gmp, cfr, eudralex,...
    • knowledge of different regulations and standards related to validation activities
    • good interpersonal relationship skills
    • good oral and written communication skills in french and english
    • problem solving and achievement oriented
    • to be a good team player in order to succeed in each validation project and routine activities
    • to be able to use a risk-based approach for problem solving and prioritisation of tasks
    • sense of urgency
    • university degree (biotechnology, agronomy, chemistry or pharmacy)

    key responsibilities

    • ensure qa oversight in validation activities (iqoq, pq, pv,...)
    • review / approve the validation documentation regarding the gmp requirements and the procedures
    • ensure that production practices are aligned with validation conclusion
    • attend all project meetings as qa validation representative
    • ensure timely escalation to management of critical issues during validation
    • contribute to the deviation process providing qa oversight and approving deviation for deviations related to validation activities and / or impact of manufacturing deviations to validation activities
    • pro-actively identify potential quality and compliance risks and manage these risks through the risk register and quality plan process
    • work in autonomy with supervision / coaching
    • to define the validation strategies through the change control process
    • to write and implement some validation documentation (validation plan, validation summary report, risk assessment, gap analysis, periodic review,...)
    • to ensure the correct application of the validation quality systems in the field and to define improvement plan as required
    • to support the production, qa and technical service teams in the implementation of the validation activities

    key benefits

    consulting

    we offer an attractive salary with extra-legal advantages:

    • group insurance
    • hospitalisation insurance
    • meal vouchers of 7 euros gross per working day
    • reimbursement km or company car
    • monthly allowance (80 euros net per month)
    • a 13th month
    • training
    • etc
    a rate as freelance is also possible
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Scadenza: 31-12-2025

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