Expériences — Ludivine RICHARD

Experiences

IT Infrastructure Qualification and regulatory support for IT activities processes
RFI/RFP formalization
Processes design and detailed user requirement specifications for Regulatory Affairs activities
Computerized Systems GxP Compliance Training & personalized support in the development of associated skills
Information Security Management System Rollout (ISMS)

ISO 27001 certification preparation (France and Italy)

Documentation writing, SOP, work instruction, monitoring, operational checks
• IT asset lifecycle and inventory
• computer room and physical security
• patch management
• access management

Modelization of work processes / workflow diagrams

Workshops facilitation with the IT, HR and legal teams

Conducting Interviews of IT Leaders, situation analysis, picture overview

Supplier security assessement
--- Governance ---
• process modelization (diagram flow + related activities description)
• methodology for assessment - simple & flexible
• periodic review strategy
--- Operational Activity ---
• carrying out supplier evaluations
• use of the secure score card platform, CSA reports
• exchanges, interviews with suppliers
• drafting of the evaluation guide based on questionnaire
• drafting of the evaluation report, conclusion and internal recommendation of reliability of the supplier
=tool=Excel, Score Card, Confluence

Presentation of the ISO 27002 standard controls
- organizational
- people
- physical security
- legal
- technical
Risk Register
--- Governance ---
• risk classification methodology
--- Operational Activities ---
• risk collection
• assessment
• mitigation
• remediation measure
• acceptance
• follow-up
=tool= Confluence

Remediation plan
• prioritization
• affectation
• follow-up
=tool= Jira
ITS Lifecycle Audit including IT infrastructure and security based on GxP regulations and cybersecurity referential (preparation, conduct and reporting)

Strategy | Steering and Governance for the activities related to the GxP Compliance of CS for the company group (international)
• Construction and implementation of the service offer
• Management of the service center and tutoring of an apprentice
• Definition of the Business Plan, Roadmap and Projects prioritization to 2021-2025
• Participation in Inspections and Audits
• Central Systems Validation Master Plan
• Animation of the international community of computerized systems validation
• IT infrastructure qualification strategy
• Training & Onboarding for newcomers related to the GxP compliance of computerized systems

Success: Definition and structuring of the service offering, Confidence, Efficiency, Creation of an international community, Integration of IT quality reflexes
Communication Skills
Operationnal | Computerized Systems Validation for centralized and deployed IS (Core Model and Roll-Out)
• Construction of compliance dossier for several systems | Validation deliverables (Validation Plan and Report, Risk Analysis, Protocols, Deviations, Incidents, Test, Report, Migration - keywords: IQ/OQ/PQ).
• Impact analysis and definition of the maintenance of compliant systems in operation
• Support for the definition of processes and needs, writing of user guides, administrator, technical architecture file, data flow, functional risk assessment
• Processing of GxP changes, incidents, problems and validation non-conformities (ITSM), deviations, CAPA etc.

Success: Record time to build the ITSM compliance file despite the health context
Cybersecurity
• Construction, implementation and management of a cybersecurity awareness program for the company's 6000 employees
• Reporting of the activity and management of the weekly points of the network and security team with the objective of structuring and making visible the different technical projects

Success: Involvement of international IT platforms, phishing simulation campaigns and e-learning strategy (contents, planification, "bad-clickers" "VAP", etc.)
IT Business Partner & Project Management
• Support for the definition of user requirements for the digitization of the global archive management process, RFP contribution
• Fluidification of relations - Interface with Business - IT - Purchasing - Legal departments
• Contribution for implementing an IT project management methodology
• Realization of the associated opportunity study and selection of the supplier
• Contribution to the investment committee presentation

Success: Supplier selection process, integration of GxP constraints, acceptance by the investment committee.

Day of pedagogical course (Evaluation Unit - Validation of Information Systems)
• Teaching and discovery of the basic principles and regulations associated with the management of computerized systems in a pharmaceutical environment.
International Symposium (intervention as conference)
• Provide an understanding of computerized systems used in the pharmaceutical industry, access management and data integrity principles (ALCOA) | International Master's Degree Chemical Analysis and Quality Control of Drugs and other Health Products
TRAINING, TRANSMISSION OF KNOW-HOW/BEING, GAMIFICATION, EDUTAINMENT, LUDOPEDAGOGY, COMPREHENSION, PARTICIPATION, EVALUATION

Intervention 2 to 3 days per year in university courses

Face-to-face or distance learning sessions. Creation of dynamic and fun practical exercises allowing a better approach to the memorization of the basic principles of the demonstration of the computerized systems compliance used in the pharmaceutical environments
Animation of educational games aimed at memorizing ALCOA principles

Detailed Description

UE3 La validation des systèmes informatisés - LTPIB - LP Métiers de la Qualité : Parcours Industries de Santé & Laboratoires de biologie médicale et établissements de santé
-> Sensibiliser les élèves à la validation des systèmes informatisés
Session en présentiel ou en distanciel. Création de travaux pratiques dynamiques et ludiques permettant une meilleur approche de la mémorisation des principes de base de démonstration de la conformité des systèmes informatisés utilisés en environnement pharmaceutique
Analytical Development Symposium: Research Versus Industry
-> Présenter les grands principes de la validation des systèmes informatisés en environnement pharmaceutique, animation de jeux pédagogiques à visée de mémorisation des principes ALCOA

Mangement of the validation project for a Computerized Maintenance Management System (CMMS)

• Resumption of the User Requirement Specifications (URS)
• Validation strategy definition and data migration in accordance with the regulations, good practices and internal procedures of the company
• Functional risk analysis review and data integrity analysis
• Support of junior staff in the realization of activities and elaboration of deliverables used to build the Coswin system GxP compliance set of documents
• Advice and recommendation related to the software configuration during weekly projects meetings to fluidify and lighten the process of demonstrating conformity
• Creation of a model documentary package (set of template documentation) for system and data migration (Plan, Tests, Reports)

Success: Inter-company cooperation – one of the junior staff was from another company
IT Infrastructures Qualification – Definition & Implementation of a strategy

• Assessment of the maturity level of the key process of the IS department
• Situation Analysis | Advice adapted to the context | Gaps identification related to the management of IT platforms and activities related to their operation
• Audit animation | Opening/closing meeting | Formalization of synthesis and action plan | Audit report
• Construction of a roadmap for the preparation of the compliance project
• Elaboration of the IT infrastructure qualification strategy, including the drafting of a qualification procedure and master plan
• Planification and definition of a prioritization methodology for the qualification of infrastructure components, assistance in carrying out the inventory
• Creation of the documentary package allowing the qualification of the elements identified as “GxP” (Plan, Test Checklist, Report, IT service provider audit)
• Training kit for the operational teams

Success: Creating a link between technical-oriented IT teams and quality-oriented qualification/validation teams.
Management of Computerized Systems Validation projects

• Organization of the biomedical subsidiary local system validation following reorganization
• Monthly presentation of the status of the validation of the IS of the perimeter, maintenance of the schedules
• Launch of compliance projects and validation files for existing systems
• Documentary review of the main deliverables and models
• Resumption of inventories of computerized systems
• Management of a junior whose first experience in IS validation
• Participation in the resolution of deviation/CAPA/changes
• Periodic system review
• Internal training

Success: Evolution and positive communication in the context of a special relationship between IS management and quality assurance
Qualification strategy for excel sheet systems

• Creation of a compliance and validation kit for excel file system (standard URS, protocol, standardized test sheet, report, training material)
• Setting up of the follow-up of the implementation of the compliance

Success: Business operational teams are convinced of securing access and data from Excel-type files used in a regulated context
Validation of computerized systems in the quality control laboratory

• Management of two validation projects for computerized systems used in the quality control laboratory
• Supervision and development of validation skills of a “Junior” consultant (mission carried out in pair)
• Writing of System Validation Plans, Functional Risk Analyses, Qualification Protocols (QI/QO/QP), QI Test Scripts, Qualification Reports, Traceability Matrix, Final Validation Report
• Support on execution of QO/QP tests

Success: Assembly of the two validation files with beginner key user, a junior consultant and a period falling in the month of May in record time and deadlines. The project was more than efficient
IT infrastructure qualification – Definition & Implementation of a Strategy

• Assessment of the maturity level of the key process of the IS department
• Situation analysis | Advice adapted to the context | identification of gaps in the management of the IT platforms and activities related to their operation
• Audit animation | Opening/closing meeting | Formalization of synthesis | Audit report
• Construction of a road map for the preparation of the compliance
• Elaboration of the IT infrastructure qualification strategy, including the drafting of a qualification procedure and master plan
• Planning and definition of a prioritization methodology for the qualification of infrastructure components, assistance in carrying out the inventory
• Creation of the documentary package allowing the qualification of the elements identified as “GxP” (Plan, Test Checklist, Report, IT service provider audit)
• Training kit for the IT operational teams

Success : New recurring missions assigned by the client.
Data Integrity and IS GxP Compliance Audit

Control of IS data integrity
• Assessment of IS life cycle maturity and associated quality processes
• Situation analysis | Advice adapted to the context | Gap identification
• Audit animation | Opening/Closing meeting | Formalization of synthesis | Audit reports
• Provision of recommendation | Elaboration of an action plan
Validation of an ERP

• Realization and review of deliverables related to the validation process (user requirements, validation plan, risk analysis, test plan and script, traceability matrix, report)
• Elaboration of an audit grid for an outsourced IT service provider

Success : Adjusting the system validation effort to the context and scale of a very small company.
Qualification documentation review during the implementation of new infrastructure components

• Review and approval of quality documentation related to IT infrastructure (server, network, storage, virtualization, backup): requirements specification, plans, risk analysis, protocols, test cases, reports
• Contribution to the development of the company’s quality culture
• Provide expertise in terms of methodology to meet the company’s IT quality standards
Review the methodology for the qualification of internalized hosting spaces

• Harmonize the qualification process for IT hosting spaces in collaboration with the US teams

Success: methodology that has become a recognized reference everywhere at a big pharma
Change Advisory Board

• Evaluation of the impact of changes on IT infrastructure
• Support for the change of practices during the modification of the ITSM

Success : Raising awareness of the people involved to reduce the number of refusal of changes
IQTC Training

• Creation of training materials
• Training of newcomers to the principles of validation of computerized systems and of IT teams in the process of installation, qualification and execution of test cases

Success : Work in an international environment – be managed remotely from the US by a non-French speaking person

Methodology Expert Role
Infrastructure Quality Expert Role
Give Quality Training Curses
Approve ITS Changes as ITS Quality Representative (Change Advisory Board)
Computer Facility - specifications and methodology update
Advice and Support central application Validation Expert on infrastructure

Detailed Description

Provide support on the ITS quality methodology, related processes and best practices and ensures that they are followed
Provide training on the IQ strategy, as needed
Ensure that this strategy is followed by the project team
Approve infrastructure Installation Procedure
Approve infrastructure IQ Forms/IQ Test Cases BEFORE
Creation and maintenance of IQ package for deployment projects
Ensure that the site IQ Documentation is produced
Approve the Multi-Sites Infrastructure Qualification Design
Approve the Validation Infrastructure Qualification Report

Management of the validation projects of 4 computerized systems (Analyst, LabX, Autoclave Fedegari, Scad5)
Transfer of skills and knowledge
Writing and Review of Validation Project Deliverables - User Specifications, Validation Plans, Risk Analyses, Qualification Protocols, IQ/OQ/PQ Test Scripts, Qualification Reports, Traceability Matrices, Final Reports
Supervision and development of junior consultants

Management of two validation projects for computerized systems used in the quality control laboratory
Supervision and development of skills in validation of a "Junior" consultant (mission conducted in pairs)
Writing of System Validation Plans, Functional Risk Analyses, Qualification Protocols (IQ/QO/QP), IQ Test Scripts, Qualification Reports, Traceability Matrix, Final Validation Report
Support on execution of QO/QP tests

Computerized Systems Validation

o Management of validation projects in the areas covering the life cycle of a drug and support functions (R&D, Pharmacovigilance, Quality Control Laboratory, Production, Quality, IT Infrastructure)
o Definition of the validation strategy for each type of computerized system
o Organization of schedules, performance analysis of validation projects and recommendation of an optimal organization around the systems in order to reduce the overall validation load
o Training, awareness and animation of project teams
o Monitoring of all validation projects
o Maintaining the validated status of all the computerized systems under my responsibility
o Justification of computerized system validation methodologies and presentation of validation files during inspections by authorities
o Elaboration of deliverables related to the validation of computerized systems (URS/ validation plan/ risk analysis/ protocols/ tests/ qualification reports/ validation reports/ procedures/ forms/ instructions/…)
o Monitoring of new regulations, writing letters, etc.
o Audit and evaluation of software suppliers
IT Administration and Support for GxP regulated application

o Resolution of technical problems
o Qualification and compliance management of the IT assets used in a regulatory context
o Global Empower Administrator
o Technical configuration assistance
Support R&D department IT domain management

o Collection and formalization of user needs
o Participation in the selection of tools and suppliers of IT solutions
o Follow-up and management of the implementation of new solution and evolution of IT tools
o Management of services (acquisition/ replacement of computerized systems, qualification execution)
o Project delivery planning

Company Description

Pharmaceutical Veterinary Industry

Participer à l'ouverture générale du magasin de Libourne
Implanter des produits
Tenir le magasin en bon état
Assurer l'ouverture et la fermeture
Réaliser l'inventaire
Accueillir les clients
Tenir à jour le tableau de bord (gestion des ventes, etc)
Réceptionner les commandes, les vérifier, réaliser les entrées/sorties de stock

Appui au Correspondant du Système d'Information

RTE - TESO - EM

September 2007 to September 2009

Apprenticeship

Mérignac

France

Traiter les audits de sécurité & maîtrise du parc informatique (revues de conformité)
Réaliser des bilans et plans d'action, présenter les résultats en réunion
Assister les employés sur l'utilisation des outils informatiques, la téléphonie et les périphériques
Restructurer l'arborescence des répertoires partagés du serveur (groupes utilisateurs, permissions NTFS, etc)

Detailed Description

Dans le cadre de la politique sécurité du SI de l’entreprise, j’ai eu à mener 4 audits de sécurité : en 2 ans, le nombre de non-conformités a quasiment été divisé par 4. Lors de mon arrivée dans l'entreprise, la politique prévoyait 3 audits par an ; il est aujourd'hui de 2 par an.

Assurer l'ouverture de la surface de vente, la remise en service des caisses
Recharger le distributeur automatique de billets, réceptionner certaines commandes
Former des nouvelles hôtesses de caisse
Fidéliser les clients à la carte du magasin, leur proposer la livraison à domicile
Gérer les cadeaux fidélités (attribution aux clients, gestion des stocks)
Facing - réaliser les têtes de gondole
Décorer le magasin (Noël, évènements)
Prendre à ma charge la caisse de la manager, les clés de remise en service et de la réserve
Mettre à la disposition des clients différents magazines

Detailed Description

Très vite intégrée au sein de l'équipe, j'ai rapidement évolué dans ce poste. Il m'a été confié des responsabilités supplémentaires telles que la gestion des cadeaux fidélités (attribution aux clients, gestion des stocks...), la délégation des clés de remise en service, etc.

Accueillir et traiter les demandes des clients (vente, diagnostic, conseil,etc)
Assurer le changement de pièces, réparer, entretenir et préparer du matériel informatique
Etablir les fiches de SAV
Vendre du matériel informatique, assister et conseiller les clients

Créer des formations et initier les élèves à l'informatique (de la maternelle au CM2)

Detailed Description

Appuyée par l'équipe pédagogique et l'informaticienne de l'école, le but était d'apprendre aux enfants à se servir d'un ordinateur, de leur en initier les bases de fonctionnement et d'utiliser certains outils comme le traitement de texte.

entretenir et nettoyer les sols et les machines de l'usine de LU

Detailed Description

La surface de nettoyage à réaliser était conséquente (toute l'usine) et à effectuer dans le temps imparti. Travail en 3x8 sur les week-end, le nettoyage s'opérant durant le premier tiers (6h-14h).

récolte saisonnière du raisin (vendanges sur 2 années consécutives)

Votre navigateur est obsolète !

Ludivine RICHARD

INFORMATION SYSTEMS | QUALITY | GxP COMPLIANCE & VALIDATION | DATA INTEGRITY | CYBERSECURITY

French

Consulting Engineer

Corporate Computerized Systems GxP Compliance Management

Temporary Teacher for University

Validation and Compliance Engineer for Information Systems

Infrastructure Quality Expert

Validation and compliance engineer for information systems

System Validation Manager

CSV Project Leader

Commerçante/Vendeuse

Appui au Correspondant du Système d'Information

Hôtesse de caisse

Technicienne SAV

Assistante informatique

Agent de Propreté

Ouvrière Agricole