Ingénieure / Ingénieure Assurance Qualité - Industrie Pharmaceutique
Core
Ensure compliance with the Quality Management System (SMQ) and Good Manufacturing Practices (GMP) in pharmaceutical production sites.
Role type
Quality Assurance Engineer (Pharmaceutical Industry)
Builds
Production batches and regulatory compliance documentation
Domain
Pharmaceutical manufacturing / Quality Assurance
Required skills
Data analysis, Audit preparation and follow-up, CAPA management, Batch record review, Protocol review, Non-conformance resolution, Regulatory standards knowledge (FDA CFR, GAMP 5, BPF, ICH, ISPE), Quality tools proficiency
Preferred skills
English (B2)
Responsibilities
Collect and analyze quality data on production sites, Prepare and follow up on audits and self-inspections, Manage deviations and CAPAs, Review batch records and protocols, Resolve non-conformities
Seniority
Mid-level (3+ years experience)
