Biologe (m/w/d)
Core
Maintaining and developing the Quality Management System (GMP) for a biopharmaceutical stem cell company developing cell therapies for rare diseases.
Role type
Quality Assurance Specialist (GMP)
Builds
Proprietary ABCB5-positive mesenchymal stem cell therapies for severe immunological and inflammatory conditions
Domain
Biopharmaceuticals / Regenerative Medicine / Rare Diseases
Required skills
GMP regulations, Quality Management Systems, Batch Record Review, CAPA/Change management, Supplier qualification, Risk analysis, Document control, Validation (CSV, URS/DQ/IQ/OQ/PQ)
Preferred skills
Computer System Validation (CSV), Qualification document creation
Technologies
eDMS, electronic Batch Records, LIMS
Responsibilities
Maintain and develop the QM system (GMP), Review and maintain GMP documents/SOPs, Conduct Batch Record Review, Manage deviations and CAPA processes, Plan and conduct training, Support validation and qualification activities, Perform self-inspections
Seniority
Mid-level, hands-on IC
