Hybrid GxP CSV Specialist – Cloud Validation Expert

INSTITUT DE RECHERCHE PIERRE FABRE SAS; Pechbusque; Hybride; EUR 50 000 - 70 000; Plein temps

Avantages offerts par ce poste

Profit-sharing

Health insurance

25 personal holidays

Public transport participation

Résumé du poste

INSTITUT DE RECHERCHE PIERRE FABRE SAS is seeking an experienced professional to join their IS Validation & Compliance team in Pechbusque. This role involves applying and maintaining the Group IS validation framework on R&D Pharma systems, ensuring compliance with GxP and related regulations.

The ideal candidate will have a Master’s degree in IT or relevant fields, possess a minimum of 5 years’ experience in IS validation, and show proficiency in both English and French. The position offers attractive benefits including profit-sharing and multiple holidays.

Qualifications

• Minimum 5 years’ experience in IS validation / CSV in a GxP-regulated environment.
• Experience with cloud system validation and maintaining a validated state.
• Strong knowledge of Computer System Validation (CSV), GAMP 5, and 21 CFR Part 11.

Responsabilités

• Apply and maintain the Group IS validation framework on R&D Pharma systems.
• Ensure compliance with GxP, GAMP 5, 21 CFR Part 11, and internal Quality procedures.
• Act as a validation point of contact for IS projects and operational activities.
• Contribute to System Lifecycle Management (On-Premise & Cloud).

Connaissances

IS validation

GxP compliance

Cloud system validation

Computer System Validation (CSV)

Risk-based approaches

Automated validation/testing

English (C2)

French (Fluent)

Formation

Master’s degree in IT, Quality, Life Sciences, or equivalent

Outils

ALM/documentation tools

Description du poste

INSTITUT DE RECHERCHE PIERRE FABRE SAS is seeking an experienced professional to join their IS Validation & Compliance team in Pechbusque. This role involves applying and maintaining the Group IS validation framework on R&D Pharma systems, ensuring compliance with GxP and related regulations.

The ideal candidate will have a Master’s degree in IT or relevant fields, possess a minimum of 5 years’ experience in IS validation, and show proficiency in both English and French. The position offers attractive benefits including profit-sharing and multiple holidays.