Assurance Quality Expert

il y a 13 heures

Saclay, Île-de-France Excelya Temps plein

Excelya: Your Future Starts Here

At Excelya, we pride ourselves on being a leading mid-size Contract Research Organization (CRO) with over 900 passionate professionals dedicated to improving healthcare. Our core values of Audacity, Care, and Energy guide our actions and decisions as we work collaboratively to drive innovation in clinical research.

Position Overview:

We are currently looking for a knowledgeable and detail-oriented Quality Assurance Expert specializing in Computerized Systems (CS/QRM) to join our dynamic quality assurance team. In this role, you will be instrumental in ensuring the compliance, quality, and effectiveness of our computerized systems and the associated quality risk management processes.

Main Responsibilities:

  • Ensure compliance and validation of Computerized Systems in alignment with GxP requirements and internal guidelines
  • Define and implement risk-based validation strategies based on system criticality (data integrity, patient safety, product quality)
  • Review existing validation documentation and oversee proper management of deviations or issues
  • Supervise outsourced validation activities, including deliverables review, KPIs monitoring, and adherence to internal procedures
  • Support validation activities across Agile and V-model lifecycle projects
  • Provide guidance and expertise to teams on Computerized System Validation best practices
  • Deliver training sessions to internal stakeholders on validation principles and compliance expectations
  • Conduct initial and periodic risk assessments of computerized systems
  • Participate in audits, supplier assessments, and provide input during regulatory inspections
  • Contribute to the implementation and follow-up of corrective and preventive actions (CAPA)
  • Monitor regulatory evolution and assess impacts on CSV processes and documentation

About You

We are looking for candidates with a strong background in quality assurance and computerized systems:

  • Experience: Strong experience in quality assurance with a focus on computerized systems validation in the pharmaceutical or biotechnology sector.
  • Skills: Strong knowledge of GxP regulations (preferably GCP, GVP, GCLP, GLP, GMP) and proven experience in Computerized System Validation and compliance in a regulated environment
  • Education: Bachelor's degree in Life Sciences, Computer Science, or a related field.
  • Languages: Proficiency in both English and French is required.

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.

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