Biologe (m/w/d)
Core
Ensuring GMP compliance and regulatory conformity for technical changes, deviations, and facility qualification in Site Engineering.
Role type
GMP/Compliance Manager (Site Engineering)
Builds
Pharmaceutical manufacturing facilities and systems
Domain
Pharmaceutical industry, GMP/Regulatory compliance
Required skills
GMP compliance, Change Control, deviation management, risk analysis, audit preparation, SOP creation, facility qualification, computerized system validation
Preferred skills
Sterile manufacturing knowledge, EU-GMP Annex 1 expertise, engineering background
Technologies
GMP documentation software, computerized systems for qualification
Responsibilities
Create and analyze deviations, manage change control processes, conduct risk assessments, support internal/external audits, prepare for inspections, develop SOPs, perform engineering operator reviews
Seniority
Mid-level, hands-on IC
