Ingénieur qualité/Ingénieure qualité
Core
QA Engineer specializing in process and cleaning validation to ensure regulatory compliance of pharmaceutical operations.
Role type
QA Engineer (Process & Cleaning Validation)
Builds
Production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Domain
Pharmaceutical industry + GMP regulatory compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Process validation (Stage 1, 2, 3), Cleaning validation (IQ/OQ/PQ, worst-case studies, MACO/LD50 calculations), GMP guidelines (ICH Q7/Q9/Q10, EU GMP, 21 CFR Part 211), Deviation/CAPA/Change control management, Regulatory audit preparation, QMS maintenance, Documentation management (DMS/QMS, LIMS)
Preferred skills
German language proficiency
Technologies
DMS, QMS, LIMS
Responsibilities
Plan, write, and execute cleaning validation protocols; Validate manufacturing processes per ICH/FDA/EMA guidelines; Maintain validation dossiers and action plans; Manage deviations, CAPA, and change controls; Collaborate with Production, R&D, and Regulatory Affairs; Participate in internal audits and regulatory inspections; Monitor regulatory guideline updates
Seniority
Mid-level, hands-on IC
