Business IT manager – CSV - Wavre, België - SGS Group Belgium

Beschrijving

SGS is the world's leading inspection, verification, testing and certification company. The company employs over 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

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

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