Clinical QA Auditor — Compliance & CAPA

Excelya Group; Paris; Sur place; EUR 45 000 - 65 000; Plein temps

Résumé du poste

A leading mid-size CRO is looking for a candidate to join their Clinical Quality Assurance team. The role includes conducting audits, ensuring compliance with regulations, and supporting teams in a clinical research environment. The ideal candidate will have a strong understanding of GCP, excellent communication skills, and a Bachelor's degree in life sciences or a related field. Fluency in French and English is essential. Join us to grow within an innovative company dedicated to improving healthcare.

Qualifications

• Previous experience or strong understanding of GCP Quality Assurance.
• Fluent in French and English (written and spoken).

Responsabilités

• Conduct internal and external audits related to clinical research.
• Prepare audit plans, perform risk assessments, and document findings.
• Ensure timely and effective implementation of CAPA.
• Support teams during regulatory inspections.
• Review and contribute to SOPs and quality documents.
• Provide training and quality guidance.
• Monitor regulatory and industry updates.
• Participate in continuous improvement initiatives.
• Maintain accurate documentation according to QA standards.

Connaissances

Knowledge of ICH-GCP

Experience in audit conduct

Interpersonal skills

Ability to analyze compliance risks

Formation

Bachelor’s degree in life sciences or related field

Description du poste

A leading mid-size CRO is looking for a candidate to join their Clinical Quality Assurance team. The role includes conducting audits, ensuring compliance with regulations, and supporting teams in a clinical research environment. The ideal candidate will have a strong understanding of GCP, excellent communication skills, and a Bachelor's degree in life sciences or a related field. Fluency in French and English is essential. Join us to grow within an innovative company dedicated to improving healthcare.