Regulatory Affairs Coordinator maintaining regulatory documents for research projects at Geneva. Overseeing IRB application processes and supporting research staff with documentation and compliance.
About the role
- Lead Compliance Manager responsible for GMP/GDP compliance in quality management for pharmaceutical company. Overseeing audits, inspections, and training at Ilios Santé GmbH in Frankfurt.
Responsibilities
- Ensure GMP-compliant manufacturing
- Ensure compliance with Good Distribution Practice (GDP) for all wholesale activities
- Plan, coordinate and support internal audits and external inspections
- Monitor and manage the system for deviations, changes (Change Control) and complaints
- Final review and approval of quality-relevant documents
Requirements
- Degree in a natural science (e.g., Pharmacy, Chemistry, Biology, Biotechnology) or an equivalent qualification
- Several years of solid professional experience in quality assurance within a pharmaceutical company (manufacturing or wholesale)
- Thorough knowledge of GMP and GDP regulations
- Business-fluent German and English, both written and spoken
Benefits
- Flat hierarchies
- Fast decision-making processes
- Autonomy
- Professional development opportunities
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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