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Business IT manager – CSV

Job Description

Your mission :

MANAGE BUSINESS IT TEAM WITHIN A GMP ENVIRONMENT

  • People management (support, evaluation, hiring)
  • Organization of the team and assignment of the projects/tasks to the member of the team
  • Participation to customer audit and authorities’ inspections
  • Define priorities in collaboration with operational managers.

    • 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

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    Business IT manager – CSV

    Entreprise:
    SGS
    Ville:
    Wavre
    Type de contrat: 
    CDI, Temps plein
    Catégories: 
    Informatique, IT Project Manager, Responsable Support
    Diplôme: 
    Master
    Niveau de carrière: 
    Manager
    Publiée:
    14.02.2024
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