Project specification
Period 18.05.2026 - 20.09.2026
Location Germany
Capacity from 95%
Remote up to 100%
Languages
German(Advanced)
English(Advanced)
Project expertise
Industries
Pharmaceutical
Business 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 goal of the project is to carry out internal and external audits, prepare and support regulatory inspections, and identify compliance gaps and derive corrective actions.
The role includes planning and executing audits, supporting regulatory inspections, and ensuring compliance with ICH guidelines as well as EMA/FDA regulations.
- Perform 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 lab compliance
- Hands-on experience with ICH guidelines and EMA/FDA regulations
- Proven experience in audit planning and CAPA management
- Understanding of clinical study 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
Where is the project located?
The project is based in Germany.
What is the duration of the project?
The project preferably starts in May 2026 and is planned to end in September 2026 (4 months).
What is the expected workload for the project?
The project requires a commitment of 95 - 100% capacity (full-time).
What is the remote work policy for the project?
The project offers 0 - 100% remote work.
What language skills are required for the project?
The project requires the following languages: German (Advanced) and English (Advanced).
Which industries is the project related to?
The project is related to the following industry: Pharmaceutical.
Which business areas does the project cover?
The project covers the following business area: Quality Assurance.
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How to apply for the project?
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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