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Business IT project manager – CSV
Business IT project manager – CSVSGS Australia • BE
Business IT project manager – CSV

Business IT project manager – CSV

SGS Australia • BE
30+ dagen geleden
Functieomschrijving

Description de l'entreprise

SGS is the world’s leading inspection, verification, testing and certification company. The company employs over 97 000 people and operates a network of more than 2 600 offices and laboratories around the world.

SGS Life Sciences is a leading contract research organization offering Clinical Research Drug Development and Quality Control / Laboratory Testing Services to the pharmaceutical and biopharmaceutical industry. It provides outsourcing services on both the quality and safety of drug ingredients and the drug development process – from the early development stages until the commercialization of the finished product.

To strengthen our Business IT team, we are currently looking for a  Business IT manager – CSV

Description du poste

Your mission :

MANAGE INDEPENDENTLY COMPUTERIZED SYSTEM VALIDATION PROJECTS WITHIN A GMP GLP BUSINESS ENVIRONMENT

  • Create detailed project planning and project teams.
  • Establish and follow the budget.
  • Coordinate and follow all project tasks and make sure progresses are made.
  • Try to solve and report potential issues and problems.
  • Collaborate with regional IT for projects development and implementation.

KEY BIT REPRESENTATIVE IN MULTIDISCIPLINARY PROJECTS

  • Prepare / collect the URS and Functional specifications.
  • Outline Test and validation plan / protocols / test cases.
  • Perform or witness test executions.
  • Write validation reports and procedures.
  • Manage / Perform Periodic Reviews to ensure the system stays in a validated state.

    • ENSURE AND ORGANIZE BUSINESS APPLICATIONS FUNCTIONAL SUPPORT

  • Work with the managers of the site to define the super users – and back ups
  • Manage the change control requests and interface with regional IT

    • Qualifications

    Your profile :

    QUALIFICATIONS / EDUCATION

  • University degree in (life) sciences with affinity for Information Technology or university degree in Information Technology with affinity for (life) sciences or equivalent experience.
  • Languages : French / English

    • EXPERIENCE

  • Very good knowledge on computer system validation, GAMP, 21 CFR Part 11 and other related regulations.
  • Proven experience as an independent validation project leader in the pharmaceutical industry, preferably GMP GLP.

    • SPECIFIC REQUIREMENTS AND / OR COMPETENCES

  • Good knowledge and big interest in IT
  • Flexibility / Good planner / Team player / Good communication and reporting skills

    • Informations complémentaires

  • Perm contract
  • Full Time
  • Attractive salary
  • Company car and other advantages
    • Maak een vacature-alert aan voor deze zoekopdracht

    Business IT project manager CSV • BE

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