Ingénieur Assurance Qualité Opérationnel H/F
Core
Implementing Electronic Batch Record (EBR) systems and operational quality strategies for sterile injectable manufacturing.
Role type
Operational Quality Assurance Engineer
Builds
Sterile injectable aesthetic medicine products (hyaluronic acid)
Domain
Pharmaceutical / Medical Device / Aesthetics
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Risk analysis, Protocol validation, Change control management, Data integrity, Regulatory compliance, Process improvement, Training delivery, Reporting
Preferred skills
EBR system implementation, QDCSM performance dimensions, Technical writing
Technologies
Electronic Batch Record (EBR), ISO 13485, 21CFR Part 820, GMP, 21CFR Part 211
Responsibilities
Develop operational quality strategy for EBR project, Validate test protocols, Ensure risk analysis alignment with quality rules, Train collaborators on EBR system, Support quality during EBR production implementation, Report activities and project quality risks, Drive production line improvement initiatives, Enforce change control processes, Apply traceability and data integrity rules, Improve quality processes, Disseminate quality policy and culture
Seniority
Mid-level, hands-on IC
