Project specification
Period 01.06.2026 - 04.10.2026
Location Germany
Capacity from 95%
Remote up to 100%
Languages
German (Advanced)
English (Advanced)
Project expertise
Industries
Pharmaceutical
Areas
Quality Assurance
Description
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, and identify compliance gaps and derive corrective actions.
The role includes planning and conducting audits, supporting regulatory inspections, and ensuring adherence to 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 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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Frequently asked questions
The project is based in Germany.
The project preferably starts in June 2026 and is planned to end in October 2026 (4 months).
The project requires a commitment of 95 - 100% capacity (full-time).
The project offers 0 - 100% remote work.
The project requires the following languages: German (Advanced) and English (Advanced).
The project is related to the following industry: Pharmaceutical.
The project covers the following business area: Quality Assurance.
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To apply for the project, click the Apply button on the project page to submit your profile for review. We will forward your resume to the client and get back to you within a few days.
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