Quality Assurance & VSI

JR France; Paris; Hybride; EUR 50 000 - 65 000; Plein temps

Résumé du poste

A dynamic health company in Paris seeks a professional to manage CSV activities in Clinical Development and ensure GxP compliance. Join a team that values audacity and collaboration, contributing to innovative solutions in healthcare.

Qualifications

• Proven ability to thrive in collaborative, fast-moving environments.
• Strong knowledge of pharmaceutical regulations, especially GxP standards.

Responsabilités

• Manage CSV activities ensuring GxP compliance.
• Define validation strategies and review system documentation.
• Conduct risk assessments and support audits.

Connaissances

Organizational Abilities

Problem-Solving

Communication

Formation

Knowledge of Pharmaceutical Regulations

Description du poste

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At Excelya, we combine passion for science with enthusiasm for teamwork to redefine excellence in healthcare.

Here’s what makes us unique!

We are a young, ambitious health company representing 900 Excelyates, driven to become Europe’s leading mid-size CRO with the best employee experience. Our one-stop provider service model—offering full-service, functional service provider, and consulting—enables you to evolve through diverse projects. Working alongside preeminent experts, you will help improve scientific, operational, and human knowledge to enhance the patient’s journey.

Excelling with care means benefiting from an environment that values your natural talents, pushes boundaries with audacity, and nurtures your potential, allowing you to contribute fully to our shared mission.

About the Job

Join Excelya, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.

The mission is carried out within the Computerized Systems Quality Risk Management Division of R&D Quality Assurance. This division is responsible for ensuring GxP compliance and validation of computerized systems used throughout the R&D process.

Main Responsibilities

• Manage CSV activities in Clinical Development, Pharmacovigilance, and Regulatory Affairs, ensuring GxP compliance.
• Define validation strategies and review system documentation to support system integrity.
• Implement and maintain system compliance with standards like GAMP 5 and 21 CFR Part 11.
• Apply a risk-based approach to validation, focusing on safety, data protection, quality, and reliability.
• Oversee outsourced validation, including task definition, deliverable review, and adherence to procedures.
• Provide guidance and training on computerized system validation to internal teams.
• Conduct risk assessments and reviews, and support audits, vendor evaluations, and regulatory inspections.
• Implement CAPAs and monitor regulatory changes impacting systems and validation processes.

At Excelya, taking audacious steps is encouraged, so we’re looking for individuals who are ready to grow with us and share our values.

• Experience: Proven ability to thrive in collaborative, fast-moving environments (talent matters most to us; minimum years not required)
• Skills: Strong organizational abilities, problem-solving mindset, and excellent communication skills
• Education: Strong knowledge of pharmaceutical regulations, especially GxP standards (GCP, GVP, GCLP, GLP, GMP, RQA). Compliance with CSR (Corporate Social Responsibility) principles and policies.
• Languages: Fluency in English and French, with the ability to contribute to meetings and create documentation in both languages
• Hybrid work model: Remote work allowed, but ideally 50% on-site or at least 2 days/month at Saclay.