Assurance Quality Expert - Computerized Systems (CS/QRM)

Excelya; Saclay; On-site; EUR 50,000 - 70,000; Full time

Benefits offered by this job

Supportive work environment

Opportunities for growth

Team-oriented culture

Job summary

A dynamic healthcare organization in Île-de-France is seeking an Assurance Quality Expert specializing in Computerized Systems. In this role, you will ensure compliance and validation according to GxP standards, define risk-based validation strategies, and oversee outsourced activities. Ideal candidates will have a strong background in quality assurance within the pharmaceutical sector and require proficiency in both English and French. Excelya offers a supportive environment that values teamwork and encourages professional growth.

Qualifications

• Strong experience in quality assurance in regulated environments.
• Proficiency in both English and French is required.
• Knowledge of GxP regulations, particularly in pharmaceuticals.

Responsibilities

• Ensure compliance and validation of Computerized Systems according to GxP requirements.
• Define and implement risk-based validation strategies.
• Supervise outsourced validation activities and review deliverables.

Skills

Quality assurance

Computerized Systems Validation

GxP regulations knowledge

Risk assessment

Training delivery

Education

Bachelor's degree in Life Sciences, Computer Science, or a related field

Job description

Assurance Quality Expert – Computerized Systems (CS/QRM)

We are 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.

Requirements

About You

• 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.

Benefits

At Excelya, we combine passion for science with enthusiasm for teamwork to redefine excellence in healthcare. Our culture fosters audacity, care, and energy, providing a supportive environment that values your talents and encourages growth.