Validation Specialist IS (GxP) -CDI- F/M

INSTITUT DE RECHERCHE PIERRE FABRE SAS; Pechbusque; Sur place; 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

Overview

Pierre Fabre Laboratories is a global leader combining pharmaceutical expertise with dermo-cosmetics. The company supports consumers and patients with brands such as Eau Thermale Avène, Ducray, A-Derma, Klorane, René Furterer, and Pierre Fabre Oral Care. This role is based in Toulouse (Langlade, Oncopole) and is part of the IS Validation & Compliance team.

Responsibilities

• Apply and maintain the Group IS validation framework on R&D Pharma systems, including cloud-based GxP platforms.
• Ensure compliance with GxP, GAMP 5, 21 CFR Part 11, Annex 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) including risk assessments, impact analyses, and validation plans adapted to IaaS, PaaS, and SaaS models.
• Develop IQ/OQ/PQ strategies, including scripted and automated validation tests and traceability matrices.
• Assess and challenge vendor validation approaches, including automation, CI/CD pipelines, and cloud-native architectures.
• Define, review, and approve cloud validation strategies (e.g., AWS); leverage Infrastructure as Code and scripted controls for Installation Qualification and validation evidence.
• Evaluate supplier documentation and cloud provider compliance evidence within a shared responsibility model.
• Maintain validated state (RUN) through change and incident impact assessments, periodic reviews, access management, audit trails, and Business Continuity/Disaster Recovery validation considerations.
• Support deviation management and CAPA activities related to validated systems.
• Create, review, and maintain validation documentation in approved ALM/documentation tools; ensure evidence remains up to date and risk-based.
• Contribute to Quality documentation (SOPs, Work Instructions, templates).
• Collaborate cross-functionally with IS teams, Quality Assurance, business stakeholders, cloud providers, and external vendors; support audits and defend cloud and scripted validation approaches.
• Scope includes Clinical and regulatory systems, Laboratory and R&D Pharma Information Systems, and Cloud-based GxP platforms (IaaS, PaaS, SaaS).
• Role compatible with teleworking up to 2 days per week according to company rules.

Qualifications

• Master’s degree in IT, Quality, Life Sciences, or equivalent.
• 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 (risk-based approaches), and 21 CFR Part 11 / Annex 11.
• Experience with validation of cloud and SaaS solutions, scripted and automated validation/testing, and supplier assessments within shared responsibility models.
• Languages: English (C2), French (Fluent).

Benefits & Other Information

We offer an attractive remuneration/benefits package including incentives, profit-sharing, Pierre Fabre shareholding with matching contribution, health and provident insurance, 16 holidays (RTT) plus 25 personal holidays, and public transport participation.

EEO Statement

At Pierre Fabre Laboratories, we believe that our greatest asset is our people. We are committed to Equal Employment Opportunity and will not discriminate based on race, color, religion, creed, national origin or ancestry, sex, sexual orientation, gender identity or expression, age, disability, veteran or military status, genetic information, or any other legally protected characteristic. Reasonable accommodation may be provided to applicants with disabilities as required by law. We encourage all qualified applicants to apply.