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Quality Compliance Auditor (GCP/GCLP/GVP) (m/f/d)

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Project specification

Project duration
Period 27.04.2026 - 30.08.2026
Project location
Location Germany
Project capacity
Capacity from 95%
Remote work ratio
Remote up to 100%
Required languages
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 for and support regulatory inspections, and identify compliance gaps and 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 for 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 audit approaches
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Frequently asked questions

The project is based in Germany.
The project preferably starts in April 2026 and is planned to end in August 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.
Yes! Recommend a freelancer for the project and earn 30% of FRATCH's profits every time they get placed — for the duration of that project. Simply share your invite link with a colleague to get started.
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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