Business IT project manager – CSV

SGS

  • Vlaams Brabant Waver, Waals Brabant
  • Vast
  • Voltijds
  • 11 dagen geleden
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 – CSVYour 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
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
  • Perm contract
  • Full Time
  • Attractive salary
  • Company car and other advantages

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