Excelya

CMC Project Quality Assurance

Excelya

full-time

Posted on:

Location Type: Hybrid

Location: Orléans • 🇫🇷 France

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Job Level

Mid-LevelSenior

About the role

  • Quality monitoring of product development projects (in-house or outsourced) for CMC (Chemical Manufacturing and Control)
  • As a member of the CMC project team in the role of QA-CMC, you will ensure the overall quality of pharmaceutical development activities from the active ingredient to the investigational medicinal product (end to end)
  • Participating in the drafting and updating of quality agreements
  • Evaluating and ensuring the compliance of deliverables and development support studies necessary for the preparation of drug specification files (PSF) with current quality standards (quality review of Product Specification Files, techniques, standards, protocols/stability reports/validation and analytical transfer, expiry dates, MBR, etc.) and deliverables supporting the drafting of marketing authorisation files
  • Reviewing files for clinical batches of active ingredients and investigational injectable medicinal products with a view to their release
  • Assessing deviations, change control, anomalies, OOX, CAPA, etc.
  • Leading or contributing to the necessary risk analyses justifying the CMC development strategy
  • Also participating in due diligence.
  • The products concerned may be injectables or dry forms.

Requirements

  • Preferably a Pharmacist or Engineer with experience in sterile products and dry forms, ideally in pharmaceutical development
  • Experience: Experience in quality assurance, particularly in reviewing clinical or commercial files related to sterile products and dry forms.
  • Skills: Proficiency in GMP (including Annexes 1 and 13) and ICH regulations
  • Languages: Proficiency in English is required; French language skills are a plus.
Benefits
  • 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 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.
  • At Excelya, Care lies at the heart of what we do. We provide equal opportunities for all and foster a diverse, equitable, and inclusive workplace where humility and boldness work hand in hand. Everyone has a space to feel valued, thrive, and collaborate with purpose. Your challenges become our shared mission. Together, we transform bold ideas into reality—the Excelya way.
  • Apply today, become an Excelyate!

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
quality assuranceGMPICH regulationsrisk analysiscompliance evaluationquality monitoringdrafting quality agreementsreviewing clinical filesanalytical transferdeviation assessment
Certifications
PharmacistEngineer