Amine Ouesleti

• Supervised URS drafting • Performed risks analysis ; SIA, DIA, FRA, CCA, Vendor Evaluation... • Verified Design specifications documents (FS, HDS, SDS, P&ID...) • Coordinated with suppliers and supervised FAT and SAT activities • Drafted commissioning and qualification documents in KNEAT ; Traceability matrix, Risks analysis, protocols and reports (DQ, IQ, OQ) • Executed qualification tests • Managed commissioning and qualification events ; Non-conformities, deviations, punchlists...

• Supervised URS update • Identified impacted CDE (Critical Design Elements) using initial risks analysis and updated DS documents • Identified impacted qualification tests using initial RTM and updated DS documents • Drafted qualification documents (protocols and reports) using Track Wise Software; DQ, IQ, OQ and PQ • Verified executed protocols • Managed tests Non-conformities /deviations

• Participated in URS and DS documents update • Identified the impacted CDEs / CAs • Identified impacted qualification tests using initial RTM and updated DS documents • Performed risk analysis to design sampling plans (relative to Purified Water System PQ and EMS OQ) • Drafted qualification documents (plans, protocols and reports); DQ, IQ, OQ and PQ • Executed tests or verified executed protocols • Managed qualification events ; Non-conformities, deviations..

• Verified CPP/KPP efficacy and their accordance with current specifications • Recensed equipment in contact with plasma products and analysed their cleaning data • Identified GAPs and implemented CAPA

• Performed GAP analysis • Drove implementation of change control for qualification and validation processes improvement • Implemented Life cycle approach to improve process validation • Implemented science and risk based approach to improve equipment qualification • Updated VMP, procedures, SOP • Drafted / reviewed qualification and validation documents (Plans, risk analysis, protocols, reports...) • Supervised tests execution • Managed tests issues

• Drafted / reviewed VMP, Procedures, SOP... • Participated in URS drafting / review • Performed risk analysis ; SIA (System Impact Assessment), FRA (Functional Risk Assessment), CCA (Critical Components Assessment) • Drafted / reviewed commissioning and qualification documents ; RTM (Requirement Traceability Matrix), SAT, FAT, DQ, IQ, OQ. • Executed tests or supervised tests execution • Managed tests issues

• Implemented Quality by Design approach. • Performed researches and feasibility studies. • Performed risks analysis and DoE (Design of Experiments) • Execution or supervised execution of experiments and analyzed data • Developed manufacturing processes and analytical methods. • Provided technical support in OOS/OOT investigations

Scientific Preparatory cycle for engineering studies