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Quality Compliance Auditor (GCP/GCLP/GVP) (M/W/D)
Project info
- Period23.02.2026 - 28.06.2026
- Capacityfrom 95%
- LocationGermany
- Languages
- German(Advanced),
- English(Advanced)
- German
- Remoteup to 100%
Description
A company is looking for an experienced Quality Compliance Auditor responsible for ensuring adherence to GCP, GCLP and GVP standards. The project goal is to conduct internal and external audits, prepare and support regulatory inspections, and identify compliance gaps to derive corrective actions.
The role includes planning and conducting audits, supporting regulatory inspections, and ensuring compliance with ICH guidelines as well as 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
Requirements
- 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, 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 auditing approaches