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    Computerized Systems Validation consultant - Brussels, België - Expleo

    Expleo
    Expleo Brussels, België

    9 uur geleden

    Default job background
    Permanent
    Beschrijving

    Responsibilities

    What is your role?

    As part of the design, modification or validation of production equipment dedicated to the pharmaceutical sector, we are looking for new employees to join Expleo Life Sciences Belgium.

    If you want to invest in validation projects for computerized systems and/or automated systems in accordance with the appropriate regulations, then this role is made for you.

    What is your responsibility?

  • Participation in the development and implementation of models for the validation of the various systems;
  • Involvement in the definition of user and functional needs for new systems as well as existing ones subject to validation;
  • Review and validation of the documentation related to the different validation phases (IQ, OQ, PQ, URS and traceability matrix);
  • Execution and monitoring of system tests;
  • Creation of validation protocols and reports;
  • Guarantee of project monitoring and regulatory constraints;
  • Realization of Data Integrity audit.

    • Qualifications

    What are your competences?

  • You have an engineering degree or an equivalent;
  • You have at least 3 years of experience in the pharmaceutical or biopharmaceutical sector;
  • You are familiar with the different regulations: GMP; GAMP 5, 21 CFR 1;
  • You speak French and/or Dutch and have a good level of English.

    • Benefits

    What are your benefits?

  • A permanent contract;
  • A very large portfolio of pharmaceutical, biotechnology, medical equipment, chemical and energy customers;
  • Projects going from short term (minimum 3 months) to long term (minimum 1 year);
  • A salary package over 13.92 months including a company car, insurance, representation expenses, etc. Remuneration is negotiable and varies according to level of experience and skills.
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