Mitarbeiter Qualitätssicherung (m/w/d)
Core
Quality Assurance specialist for a chemical/pharma company manufacturing PET diagnostic precursors and kits.
Role type
Quality Assurance Specialist (GMP/ISO)
Builds
Quality management systems and regulatory compliance for PET diagnostic products
Domain
Chemical and Pharmaceutical industry, PET diagnostics
Required skills
GMP regulations, ISO 13485 audits, Change Control management, SOP creation, Quality Agreements
Preferred skills
Pharmaceutical studies, Quality Assurance experience, IT skills, English language
Technologies
GMP, ISO 13485
Responsibilities
Evaluate and coordinate Change Control requests, Review and manage Quality Agreements, Prepare for ISO 13485 audits, Create and review quality documents and SOPs
Seniority
Mid-level, individual contributor
