Offer summary

Qualifications:

University degree in (life) sciences with an affinity for Information Technology or vice versa., Very good knowledge of computer system validation, GAMP, and 21 CFR Part 11 regulations., Proven experience as an independent validation project leader in the pharmaceutical industry, preferably in GMP GLP environments., Strong communication, planning, and teamwork skills..

Key responsibilities:

Manage computerized system validation projects within a GMP GLP business environment.

Create detailed project plans, establish budgets, and coordinate project tasks.

Prepare and collect user requirements and functional specifications, and outline test and validation plans.

Ensure and organize business applications functional support and manage change control requests.

Job description

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 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