Soufiane Ghanimi

-Créer un cahier des charges pour mettre en place un GMAO adapté pour CEFF -Élaborer un plan de maintenance préventive et un plan d'amélioration continue pour divers tableaux généraux basse tension (TGBT) pour l'aéroport Charles de Gaulle -Mettre en œuvre le TPM/6S, les méthodes et outils de maintenance et d'amélioration continue afin d'améliorer et de faciliter intervention de maintenance et de garantir la sécurité des opérations. -Former et accompagner les équipes de maintenance et les sensibiliser aux méthodes de maintenance, 6S. -Proposer et Déployer des solutions point de vue technique et organisationnelle -Animer des réunions et des revues hebdomadaires de l'avancement des travaux avec le client

-Déploiement d'un nouveau flux processus Qualité -Collaboration avec différentes personnes de contact sur les sites d'Hitachi dans le monde entier -Examen de l’ensemble de la base de données au niveau du département qualité -Gérer le module QM de SAP REIWA et le QM du système de passeport DPS DIGITAL -Gestion des défauts majeurs et des déviations mineuresIntégration de toutes les fonctions de gestion de la qualité de SAP REIWA QM -Rédaction des spécifications et des procédures Data migration Review All of Preload and Post load files,Inspection plan, inspection lot ,Quality info record, Integration and Creation of work centerManage deployment of SAP S/4 HANA “ REIWA” Quality management and DPS DIGITAL passport system QM. -Deployment Training for USERS, Coaching communication Follow-up and resolution of technical problemsManage defect major and minor deviations. -Deployment PPAP Notification Creation, requirementDrafting of specification.Integration of all SAP REIWA S4 HANA quality management functions QMReview the quality database.Collaboration with different contact persons at Hitachi sites around the world and Solution designers Infosys

-Analysis of the existing system -Change management, Lean management -Coordination and information sharing - Planned changes -Task planning in collaboration with the impacted departments Addition of the UDI field (barcode on labels) -Deployment Software changes: replacement of access and codesoft 9 by Nicelabel software -Review and standardization of all other Lonza labels - Coordination and data sharing with Lonza's Walkersville site -Consider action plan -Plan and organize training test the new printers - Test, Qualify printers, -Write and introduce The change Request CRB/URS user requirement specification -Ensure IT data integrity

-Remediation project following an FDA inspection -Baseline assessment of quality systems -Review of Operating Procedures, Good Manufacturing Practices -Review of automatic and semi-automatic visual inspection deviations -Periodic audits, manufacturing surveillance and batch record review and approval. - Review and evaluation of calibration and preventive maintenance deviations, facilities - Review and evaluation of production procedures, dressings, qualifications and validations of vision systems and visual inspection of syringes

Deployment of SMED/6S with a lean approach on 4 high and low voltage metallization machines Deployment of a Kaizen culture and coaching on the animation of continuous improvement projects Coaching of production managers and operators in the GEMBA area (change management) Define a new organization of the clean room (4 cutting machines, measurement and packaging station) Define operating scenarios with several operators and the workload without waiting Deployment of camera tracking sheets for the measurement of the the vanishing line of the cut film

Coordinate activities related to production and process validation on a daily basis, according to the established schedule Investigation Cross-functional management Write and review production documents (SOP, MBR, schedules, assembly sheets, media preparation sheets, non-exhaustive list) on assigned projects Manage deviations occurring during USP production and define the appropriate CAPA (CAPA committee) Verify traceability of operations: review of batch records according to good documentation practices before approval by QA Work in relation with the production teams " Facilities, preparation of supports and preparation and assembly of material and USP ". Participate in the Project Manager's project follow-up meetings (USP technical meetings) Transfer the necessary information to the Production Team Leader so that he/she can plan and organize production operations with the team of technicians Ensure compliance with SOPs and GMP standards Process deviation investigation and batch record review

•As a RIE project manager my first role is to define a planning where we can see the steps, the tasks, dates of the events as well as the responsibilities of each one, the priority define the resources and estimate the duration of the tasks on a GANTT diagram in the Microsoft Visio •Simplify, Pilot and manage the preparation phase which lasts 4 weeks as well as the development phase which lasts 1 week then the application and stabilization phase which lasts 6weeks •Organize lean training and train people on lean philosophy, basic notions of waste, as well as the use of basic lean tools, Coaching and training (20 people) •Deployment RIE SMED BULK / Technical stops in preventive maintenance •Organize SMED training for line workers •Collect data using the organization of timing and video recording sessions of operations and interventions on the injection form filling line (Medicament innohep,) •Identify the operations that can be eliminated Simplify Combine or Reorganize • Mapping the Process, Participating in the implementation of planning of technical maintenance shutdowns •Facilitate the installation and extraction of connections with quick clamping connections •Define a schedule for the change of format by specifying that the preventive maintenance activities that must be done, will allow the team to follow the sequence of operations •Follow the implementation of actions and support for changes •Deployment of a new organization for the Inter compagne line Bulk filling syringe for injectable forms (Medicament innohep,) Result: •Progress of several RIEs according to the schedule, change of roles and attitudes of staff •Reduce the time spent between campaigns and tool changes, switching from more than 48 hours to 12 hours •Several operators and staff trained in lean •Celebrate the closure of projects in the event of success to keep the teams motivated

-Manage the displacement of a production line of the heating bodies (drawing up of the plan, analysis and simplification of the physical flows, consultation of the subcontractors and suppliers) GEMBA, Chasing the losses and the NVA - MTM analysis -Propose, test the installation of an IG028 laser sensor inside a TIG welding machine -Simulation, boiler start and control test on LabVIEW -Study Capability Rolling Machine (Sample Measurements with 3D Arm) -Simulation and boiler start and control test on LabVIEW (test steps and conditions) -Analysis causes / effects rejects welds and rejects leaks at the boiler's heating body