- 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.
- 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.
- 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.
- 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
- 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
- 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.
- Good knowledge and big interest in IT
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Business IT manager – CSV - Wavre, België - SGS
Beschrijving
Job Description
Your mission :
MANAGE BUSINESS IT TEAM WITHIN A GMP ENVIRONMENT
MANAGE INDEPENDENTLY COMPUTERIZED SYSTEM VALIDATION PROJECTS WITHIN A GMP GLP BUSINESS ENVIRONMENT
KEY BIT REPRESENTATIVE IN MULTIDISCIPLINARY PROJECTS
ENSURE AND ORGANIZE BUSINESS APPLICATIONS FUNCTIONAL SUPPORT
Qualifications
Your profile :
QUALIFICATIONS/EDUCATION
EXPERIENCE
SPECIFIC REQUIREMENTS AND/OR COMPETENCES
Flexibility / Good planner / Team player / Good communication and reporting skills
