Senior Expert Sterility Insurance

HybridOperations, PV & SafetyFull time
Gidy, Centre-Val de Loire, France
OVERVIEW
Description
About the Job
Join Excelya, where Audacity, Care, and Energy define who we are and how we work. As a Senior Expert in Sterility Insurance, you will take on a vital role in ensuring the integrity and safety of our sterilization processes within clinical development.
Your expertise will drive quality assurance in sterilization practices to comply with industry standards and regulatory requirements while fostering a culture of continuous improvement and excellence.
**Main Responsibilities**:

- Managing task lists and interacting with other peripheral streams (maintenance, logistics, etc.)
- Communicating tasks to the project manager daily and via monthly KPIs.
- Tasks and deliverables for the project and authorities:

- Risk analyses (initiation, execution, conclusion, action plan)
- Drafting quality documents (test protocols/plans and reports, standard operating procedures, operating procedures)
- GAP analysis against GMP
- Scientific justification (documents) for deviations from regulatory requirements
- Monitoring action plans, investigations, and evaluation of out-of-specification (OOS) results
- Drafting the CCS DP

**Requirements**:
About You
We're looking for an experienced professional who embodies our values and is committed to fostering excellence in sterilization processes.
**Experience**: Proven background in sterility assurance and risk management within the pharmaceutical or medical device industry (avoid requiring minimum years—talent matters most to us)
**Skills**: Deep understanding of regulatory compliance, sterilization methodologies, and GMP requirements; adept in investigations and CAPA management.
**Education**: Bachelor's degree in a relevant scientific field; advanced degree preferred.
**Languages**: Fluent in French and English; additional languages are a plus.

**Benefits**:
Why Join Us?
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.