QA Expert Qualification (m/w/d) - Quality Assurance
Core
Ensure GMP compliance and lead qualification projects for pharmaceutical production systems and processes.
Role type
Senior Quality Assurance Expert (Qualification & Validation)
Builds
Pharmaceutical production facilities, computerized equipment, and validated processes for human protein drugs.
Domain
Pharmaceutical manufacturing / GMP / Quality Assurance
Required skills
GMP compliance, Qualification & Validation, Computerized Equipment Qualification, EU GMP regulations, 21 CFR Part 211/11, GAMP5, URS/IARC/Risk Analysis, IQ/OQ/Validation documentation, SOP creation, Electronic GMP systems management
Preferred skills
Biotechnology/Chemical Engineering background, Project management, Cross-functional team leadership
Technologies
Electronic GMP systems, Databases, Validation tools
Responsibilities
Lead interdisciplinary qualification projects, Review and approve qualification documents (URS, IARC, Risk Analysis, Traceability, IQ, OQ, Validations), Plan and support commissioning of equipment, Act as internal interface for Quality with Tech/Production/Maintenance, Create and train on SOPs, Manage electronic GMP systems and databases
Seniority
Senior, hands-on IC