Global Computerized System Validation Expert

American President Lines; Courbevoie; Hybride; EUR 60 000 - 80 000; Plein temps

Résumé du poste

Une entreprise de logistique mondiale recherche un Expert en validation de systèmes informatiques pour superviser les activités de validation à l'échelle mondiale. Le candidat idéal doit avoir un Bac+5 en informatique et plus de 8 ans d'expérience en validation dans le secteur de la santé. Le poste implique la création et la revue de documents de validation, ainsi que la coordination des activités de gestion du changement. Vous travaillerez en France, principalement à Courbevoie ou à Lyon.

Qualifications

• Plus de 8 ans d'expérience en CSV dans le secteur de la santé.
• Capacité à gérer la documentation relative à la qualification et à la validation.
• Connaissance approfondie des réglementations GXP liées à la CSV.

Responsabilités

• Superviser et effectuer des activités de validation des systèmes informatiques.
• Créer et examiner la documentation de validation.
• Organiser et diriger des activités de gestion du changement.

Connaissances

Expérience en validation de systèmes

Connaissance des régulations GXP

Capacité à travailler en environnement cross-fonctionnel

Compétences en documentation et revue

Méthodologie de gestion des risques

Formation

Bac+5 en informatique ou équivalent

Description du poste

Identifiant: 557499

Courbevoie, FR

Global Computerized System Validation Expert

CEVA Logistics provides global supply chain solutions to connect people, products, and providers all around the world. Present in 170+ countries and with more than 110,000 employees spread over 1,500 sites, we are proud to be a Top 5 global 3PL.

We believe that our employees are the key to our success. We want to engage and empower our diverse, global team to co‑create value with our customers through our solutions in contract logistics and air, ocean, ground, and finished vehicle transport. That is why CEVA Logistics offers a dynamic and exceptional work environment that fosters personal growth, innovation, and continuous improvement.

DARE TO GROW! Join CEVA Logistics, and you will be part of a team that values imagination and continued learning and is committed to excellence in everything we do. Join us in our mission to shape the future of global logistics. As we continue growing at a fast pace, will you “Dare to Grow” with us?

Your Role:

Part of the global QHSE team, you are responsible to oversee and perform computer systems validation activities for global systems, ensuring that business processes required to operate are qualified and maintained in a validated state according to company directive and procedures.

You work with members of I.T., Quality Assurance, and other stakeholders to ensure that computerized system validation files are consistent.

You are the primary point of contact for the business to define and scope of global CSV projects and testing strategy based on risk.

What are you going to do?

Main areas of focus and accountability of the role – detail in order of importance the main areas of accountability of the role:

COMPLIANCE :

• IT CSV oversight for GXP computerized systems.
• Ensuring compliance with regulations (21 CFR Part 11, EU Annex 11, GAMP 5).
• Provide validation strategy to the introduction of computerized systems.
• Handling deviations, CAPAs, and change controls related to scope of function activity.

DOCUMENTATION AND REVIEW :

• Creating and reviewing validation documentation, including user requirements, validation plans, IQ/OQ/PQ documentation, risk assessments and validation reports.
• Ensure Computerized Systems are appropriately qualified and validated while conducting review of related documentation and leading quality risk assessment and change management activities.
• Lead and execute validation activities that are identified and required.
• Prepare all the documentation associated by ensuring the execution following the plan.
• Ensure that all validation activities are carried out and reported in a timely manner.
• Ensure that all deviations during validation activities are investigated and escalated when required.
• Propose action plans and ensure that correctives/preventives actions are followed and closed on time.
• For Local Computerized Systems support review user, functional and technical specifications.
• Develop test plans, coordinate and supervise testing phases and manage issues.
• Review test scripts for functional testing, regression testing and load testing.

VALIDATION SUSTAINABILITY :

• Organize and lead activities include but are not limited to; the preparation of Validation/Qualification Plans, Risk Assessments, User Requirement Specification, Traceability Matrix, Testing (IQ/OQ/PQ), Data Migration, SOPs and Change controls.
• Conduct validation training with project team communicating deliverables, procedures and methods whilst supporting the department training / education program by coaching and mentoring of new and existing employees. Provide education and training on CSV related topics to areas of the business with specific requirements.
• Represent the company to clients (internal and external) and Regulatory authorities as a CSV Lead.

CHANGE MANAGEMENT :

• Lead and coordinate change management process related to CSV and ensure validated state of systems is maintained.
• Coordinate Risk Assessment for system changes.

Travel in France to be plannes once a month depending on the location of the position.

Can be based ideallyin Courbevoie (92) or Lyon (69).

Who are we looking for?

• Bac+5 Qualification in Computer Science or equivalent.
• More than 8 years’ experience in Healthcare CSV.
• Experience of managing documentation relative to qualification and validation in compliance with quality structure.
• Experienced in establishing the procedures, policies and masterplans that define a CSV and revalidation program.
• Strong knowledge of GXP regulations related to CSV including 21 CFR par 11, EU GMP annex 11, GAMP 5.
• Knowledge of computerized system development life cycle approach.
• Ability to work in cross-functional team environments as well as independently and have the flexibility to adapt to changing priorities.
• Demonstrated mentoring of others and the ability to directly influence cross functional teams.
• Drive for Results / Action oriented / Decision Maker / Customer focus / Motivating Others.
• Capability to communicate at all levels in the organization.

As a global organization, and as part of the CMA CGM Group, diversity is critical to our business success; only when we can reflect the cultures, languages, behaviors and local knowledge of our customers, we can succeed. By employing people with different experiences and abilities, we expand our knowledge and increase our creativity and innovation.