Quality officer - Orléans

Excelya Group; Gidy; Sur place; EUR 70 000 - 90 000; Plein temps

Résumé du poste

A leading health company in France is seeking a Senior Expert in Sterility Insurance. This role involves ensuring the integrity and safety of sterilization processes within clinical development. The successful candidate will drive quality assurance and compliance with industry standards, managing risk analyses and maintaining documentation while leading multidisciplinary teams. Requirements include a scientific degree and deep understanding of aseptic operations. Join a vibrant team dedicated to excellence in healthcare, with a focus on your professional growth.

Qualifications

• Experience in sterility assurance and aseptic operations, ideally in injectable product manufacturing.
• Proven expertise in Contamination Control Strategy and Aseptic Process Simulation.
• Strong background in risk management, deviation investigations, and CAPA management within the pharmaceutical or medical device industry.

Responsabilités

• Manage task lists and coordinate with maintenance, logistics, etc.
• Communicate tasks to the project manager and report via monthly KPIs.
• Conduct risk analyses and draft quality documents.

Connaissances

Sterility assurance

Regulatory compliance

Contamination Control Strategy

Aseptic Process Simulation

Risk management

Deviation investigations

CAPA management

Leadership

Formation

Bachelor’s or master's degree in a relevant scientific field

Description du poste

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

About You

We're looking for an experienced professional who embodies our values and is committed to fostering excellence in sterilization processes.

Experience

• Experience in sterility assurance and aseptic operations, ideally in the manufacturing of injectable products under isolator.
• Proven expertise in Contamination Control Strategy (CCS) and Aseptic Process Simulation (APS) implementation.
• Strong background in risk management, deviation investigations, and CAPA management within the pharmaceutical or medical device industry.

Skills

• Deep understanding of regulatory compliance, sterilization methodologies, and GMP requirements.
• Ability to lead and influence multidisciplinary teams and foster a culture of sterility excellence.

Education

• Bachelor’s or master's degree in a relevant scientific field (Pharmacy, Microbiology, Engineering, or Life Sciences); an advanced degree is preferred.

Languages

• Fluent in French and English; additional languages are a plus.

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.