Asma Srairi

Parmaceutical Consultant Development and Industrial Transfer Project Manager @BIOCODEX

Gentilly, FR

Objectiveso Manage development and industrial transfer projects, notably for dry forms, injectable solutions, and vaginal ovules.o Oversee multiple projects simultaneously while meeting deadlines.o Lead project meetings with CMOs.o Collaborate with internal departments to ensure project success.o Prepare design dossiers for medical devices in compliance with CE certification requirements (Regulation 2017/745).Achievementso Manage technology transfer projects (batch size increase, formula change, site change, etc.).o Supervise development trials for formula changes.o Ensure adherence to schedules provided by CMOs.o Verify and validate process validation protocols and reports.o Validate stability protocols and track stability results for validation batches.o Check production batch documentation.o Validate the Project Transfer Plan (PTP).o Validate transfer or analytical method validation protocols and reports.o Evaluate project transfer costs.o Monitor regulatory changes.o Draft traceability matrices for medical device design dossiers.o Define User Requirements for medical devices as part of the design dossier.Technical Environmento EU / ICH Regulationso ISO Standardso Regulation 2017/745o Project Managemento Technical Englisho Pharmaceuticalso Medical Deviceso Drugs