Ingénieur / Technicien Assurance Qualité Opérationnel H/F
Core
Implementing Operational Quality Assurance (AQO) strategies and Electronic Batch Record (EBR) systems for sterile injectable aesthetic medicine production.
Role type
Operational Quality Assurance Engineer/Technician
Builds
Sterile injectable aesthetic medicine products (hyaluronic acid fillers)
Domain
Pharmaceutical / Medical Aesthetics
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Risk analysis, change control management, data integrity, regulatory compliance, process improvement, protocol validation, training delivery
Preferred skills
Technical English, technical writing, adaptability
Technologies
Electronic Batch Record (EBR) systems, ISO 13485, 21CFR Part 820, GMP, 21CFR Part 211
Responsibilities
Develop AQO project strategy, validate test protocols, implement risk analyses, drive production line improvement initiatives, enforce change control processes, ensure data traceability, train staff on EBR systems, disseminate quality culture
Seniority
Mid-level, hands-on IC