This role ensures compliance with GMP standards, FDA regulations, and international quality requirements while supporting global manufacturing operations
Job Summary
This role ensures compliance with GMP standards, FDA regulations, and international quality requirements while supporting global manufacturing operations.
You will implement continuous improvement initiatives, conduct investigations, and maintain quality management systems to help make the world healthier, cleaner, and safer.
The position requires working with cross-functional teams to support external regulatory inspections and manage deviation investigations alongside CAPA processes.
Matching Summary
This role ensures compliance with GMP standards, FDA regulations, and international quality requirements while supporting global manufacturing operations.
Skills & Requirements
Must-have
GMP standards compliance
FDA regulations knowledge
Deviation investigations experience
CAPA and root cause analysis
ISO 9001/13485 standards
Nice-to-have
Cross-functional team collaboration
Continuous improvement initiatives
Internal audit experience
Cleanroom environment work
Conversational German language skills
Key Requirements
Bachelor's degree with 2 years experience or Advanced degree
Experience in pharmaceutical/biotech manufacturing or QA