Description de l'entreprise
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 – CSV
Description du poste
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
Qualifications
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
Informations complémentaires
- Perm contract
- Full Time
- Attractive salary
- Company car and other advantages
