Description de l'entreprise
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
Description du poste
Your mission:
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