Lyna Benmimoun

QS & R&D QA Engineer

• Job Details:Quality oversight and support for R&D & CMC projects. Participation in supplier meetings. Verification of GMP batch records (linker payload, MAB, DS, DP & IVSS) used in clinical trials. Verification of packaging and repackaging batch records. Review of quality assurance agreements (QAA). Handling of OOS, OOT, and atypical results. QA verification of protocols, reports, and analytical methods. Monitoring and verification of GMP & non-GMP stability reports, protocols, and results. Monitoring of regulatory requirements (GMP, GXP, ICH, ISO, FDA). Review of IND & IMPD regulatory dossiers (Module 3, Quality).

Quality Assurance Internship

• Job Details:Coordination of management reviews and quality reviews. Implemented new KPIs improving compliance tracking efficiency. Handling of non-conformities. Monitoring of change controls. Follow-up on CAPAs and continuous improvement. Document management: review of procedures and technical work instructions. Management of archiving campaigns. Development of quality training materials and tools.