A company is looking for an experienced Quality Compliance Auditor responsible for ensuring compliance with GCP, GCLP, and GVP standards. The project aims to conduct internal and external audits, prepare and support regulatory inspections, as well as identify compliance gaps and derive corrective actions.
The role includes planning and conducting audits, supporting regulatory inspections, and ensuring adherence to ICH guidelines and EMA/FDA regulations.
- Conduct internal and external audits (GCP, GCLP, GVP)
- Prepare and support regulatory inspections (e.g., MHRA, FDA, EMA)
- Identify compliance gaps and derive corrective actions
- Master’s degree in life sciences, pharmacy, medicine, or quality management
- 5–10 years of professional experience in clinical research, pharmacovigilance, or laboratory compliance
- Hands-on experience with ICH guidelines and EMA/FDA regulations
- Proven experience in audit planning and CAPA management
- Understanding of clinical trial processes and documentation
- Knowledge of pharmacovigilance systems and data integrity
- Strong communication and reporting skills
- Certification (e.g., RQA) preferred
- Experience with risk-based audit approaches
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