Du poste
Your mission:
MANAGE INDEPENDENTLY COMPUTERIZED SYSTEM VALIDATION PROJECTS WITHIN A GMP GLP BUSINESS ENVIRONMENT
1. Create detailed project planning and project teams.
2. Establish and follow the budget.
3. Coordinate and follow all project tasks and make sure progresses are made.
4. Try to solve and report potential issues and problems.
5. Collaborate with regional IT for projects development and implementation.
KEY BIT REPRESENTATIVE IN MULTIDISCIPLINARY PROJECTS
6. Prepare / collect the URS and Functional specifications.
7. Outline Test and validation plan / protocols / test cases.
8. Perform or witness test executions.
9. Write validation reports and procedures.
10. Manage / Perform Periodic Reviews to ensure the system stays in a validated state.
ENSURE AND ORGANIZE BUSINESS APPLICATIONS FUNCTIONAL SUPPORT
11. Work with the managers of the site to define the super users – and back ups
12. Manage the change control requests and interface with regional IT
Qualifications
Your profile:
QUALIFICATIONS/EDUCATION
13. University degree in (life) sciences with affinity for Information Technology or university degree in Information Technology with affinity for (life) sciences or equivalent experience.
14. Languages: French / English
EXPERIENCE
15. Very good knowledge on computer system validation, GAMP, 21 CFR Part 11 and other related regulations.
16. Proven experience as an independent validation project leader in the pharmaceutical industry, preferably GMP GLP.
SPECIFIC REQUIREMENTS AND/OR COMPETENCES
17. Good knowledge and big interest in IT
18. Flexibility / Good planner / Team player / Good communication and reporting skills
Informations supplémentaires
19. Perm contract
20. Full Time
21. Attractive salary
22. Company car and other advantages