Expert (m/w/d) Science & Compliance
Core
Handling quality issues (deviations, complaints, audits) in pharmaceutical production and serving as the interface with Quality Assurance.
Role type
Senior IC quality compliance expert (pharmaceutical manufacturing)
Builds
Production quality reports, SOPs, and compliance documentation for pharmaceutical manufacturing
Domain
Pharmaceuticals + Quality Assurance/Compliance
Required skills
cGMP knowledge, Technical Writing, Root Cause Analysis, CAPA management, Audit presentation, Process deviation assessment
Preferred skills
Biotechnology/Chemistry background, Experience in pharma manufacturing, Regulatory compliance experience
Technologies
GMP, CAPA, SOPs
Responsibilities
Monitor and coordinate deviation handling in production, Lead root cause analysis and CAPA definition, Present production sites in customer and regulatory audits, Manage complaint handling with QA, Track KPIs for deviations and audit findings, Create production SOPs
Seniority
Senior, hands-on IC
