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Business IT Project Manager (H/F)
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
· 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.
SPECIFIC REQUIREMENTS AND/OR COMPETENCES
· Good knowledge and big interest in IT
· Flexibility / Good planner / Team player / Good communication and reporting skills
Intérim en vue de CDI.
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19 days left to apply
- Function type: Technical consultancy
- Sector: Industry and machine construction
- All jobs via Actief Interim
- Master (University or Higher Education Long Type)
- English, French
- Interim optional fixed contract