Cloud GxP IT Validation Specialist

Pierre Fabre Pharmaceuticals Inc.; Toulouse; Hybride; EUR 70 000 - 95 000; Plein temps

Avantages offerts par ce poste

Profit-sharing

Company shares

Health insurance

Paid holidays

Résumé du poste

Pierre Fabre Laboratories in Toulouse is seeking a Validation Specialist IS to ensure GxP Information Systems are validated, compliant, and maintained throughout their lifecycle for on-premise and cloud platforms. You will handle validation plans, IQ/OQ/PQ, risk assessments, and cloud-specific strategies.

You will work across IS, QA, and business stakeholders, supporting audits and continuous improvement in a highly automated environment.

Qualifications

• Master's degree and 5+ years IS validation/CSV in a GxP-regulated environment.
• Experience with cloud system validation and maintenance of validated state.
• English at C2 level and fluent French.

Responsabilités

• Apply and maintain the Group IS validation framework for R&D Pharma systems, including cloud platforms.
• Contribute to system lifecycle management for on-premise and cloud environments.
• Define risk-based validation strategies for cloud environments (AWS/Azure).
• Assess vendor validation approaches and automation within shared responsibility models.
• Support audits and regulatory inspections with rational explanations of validation approaches.
• Create and maintain validation documentation and quality records.

Connaissances

CSV validation

GAMP 5

21 CFR Part 11

Annex 11

Cloud validation

Automated validation

CI/CD validation

Supplier assessments

Formation

Master’s degree in IT, Quality, Life Sciences

Outils

AWS

Azure

ALM tools

Description du poste

Pierre Fabre Laboratories in Toulouse is seeking a Validation Specialist IS to ensure GxP Information Systems are validated, compliant, and maintained throughout their lifecycle for on-premise and cloud platforms. You will handle validation plans, IQ/OQ/PQ, risk assessments, and cloud-specific strategies.

You will work across IS, QA, and business stakeholders, supporting audits and continuous improvement in a highly automated environment.