Mission:Organize, manage and participate in QA activities from early-phase API manufacturing to Process Validation and in Cleaning activities.Roles and responsibilities: Management and approval of change controls, CAPAs & deviations Be the point of contact for customers quality topics (audits, customers requests, complaints and recalls) Participation in on-line problem solving with other departments Review and approval of the documentation linked to quality agreements, process optimization & validation, analytical, operations and cleaning documentation Recommend changes in practices to enhance the conformance to GMP within all departmentsResults: Deviations, CAPA and change control managed and QA approved Communication and projects followed-up with customers GMP document QA reviewed and approved Active participation in the QA NPI team

Mission:Support, handle and manage the unplanned events, CAPA and investigations associated, generated by the production.Roles and responsibilities: Deviations & CAPA Management  Change control Management Document management of the Department Establishment of Non-Environmental monthly report Housekeeping of the Department Training and coaching follow-upResults: Deviations report (impact, causes) completed CAPA's on-going & Continuous Improvement GMP document update Non-Environmental Grade A/B reports generated Housekeeping of the Department perdormed

Mission:Perform QA operational activities related to formulation operations.Roles and responsibilities: Responsible for the QA Oversight Responsible for quality decision  Responsible for deviation, CAPA and Change control completion Perform internal audit and contribute to MPU inspection readiness through gemba and documentation review Ensure that quality and cGMPs are in place and in useResults: Oversight management and follow-up based on the annual planning objectives Participation to oversight and realization of internal audit Deviations, CAPA, Change control approval Participation to an external audit as coordinator Quality documents approval

Mission:Manage process validation, systems and clean utilities activities in the respect of cGMP, health and safety rules.Roles and responsibilities: Define validation strategies of production systems and process Preparation of the validation documentation Approve/review of qualification/validation documents Execute/coordinate/review the qualification/validation tests Perform the validation impact analysis of incidents and change controls Follow-up of periodic qualificationsResults: Qualification of a new production control system (PCS7) implemented in a biopharmaceutical bulk production area to produce clinical batches Aseptic filling process validation following the implementation of a new syringe line Participation to day-to-day equipment/room qualifications and to periodic qualifications

Mission:Manage all QA operations linked to the implementation of the European serialization project.Roles and responsibilities: Ensure QA follow-up as part of the implementation of an Hypercare cell following the European serialization project implementation Ensure QA follow-up regarding issues met during the European serialization project implementation Bring QA support to the project team in charge to implement the serializationResults: Setting-up of the Hypercare team and definition of everyone’s roles and responsibilities Preparation of the different QA partners to the impact of the serialization implementation Review and approval of deviation opened as part of the Hypercare cell Ensure data integrity related to the European serialization project Participate and QA follow-up concerning artworks change linked to the project

Consultant in the biopharmaceutical industry

Mission:Management of the process validation activities for new project/product introduced onsite.Roles and responsibilities: Manage all activities linked to the process validation activities Prepare and implement the validation documentation (validation master plan, PPQ protocol and report) Participate in the FMEA elaboration Answer to all specific requests linked to process validation from agencies or clientsResults: Management of the process validation activities of 4 new products Redaction of the supportive validation documentation Use of statistical tools to interpret results

Mission:Responsible of the implementation of all site serialization projects.Roles and responsibilities: Management of internal teams to reach the objectives of the company regarding the implementation of serialization projects on the Lessines site Planning, resources, budget management for serialization projects Coordination of validation activities related to serialization projects SPOC with the Global Serialization Team of the company Collaboration with other Shire sites using serialization to harmonize the global project approaches and the validation strategiesResults: Implementation of the new company serialization center at Site level Serialization implementation for many European countries (65%) (target 02/2019) Upgrade of serialization software on all packaging lines

Mission:Implementation of a new generation of Serialization system - e.g. hardware and software - on a Packing Line.Roles and responsibilities: Ensure that all the validation activities linked to the project are prepared and implemented in time Organize, coordinate different teams and provide support to the validation activities related to the implementation of the project, specifically during validation tests Prepare and implement the validation documentation (URS, FDS, DR, DQ, Commissioning, IOPQ, final reports) Manage deviations and changes in order to ensure that they are well documented and that corrective actions are takenResults: The new generation of Serialization system has been implemented and validated within the foreseen deadlines All the validation tests have been performed, the validation documentation has been approved, the punch-list and incidents have been completed without impact on validation activities, and the new Serialization system has been implemented

Mission:Implementation of a Quality Management System software, following GAMP5 and 21 CFR part 11 requirements.Roles and responsibilities: Process understanding and definition of the user requirements Write & review of validation documentation (URS, IQ/OQ&PQ protocols, Change Control) Software configuration aligned to client processes Execute, document and report the testing results Update the documentation All users trainingResults: The Quality Management System software has been implemented and validated Documentation, deviations, OOS, CAPA and Change Controls are managed through the software

Mission:Production support for all process validations of the site.Roles and responsibilities: Participate during concomitant runs of process validation (performance qualification) Create and manage Change Controls Manage deviations related to process validations Train staff to the new procedures Review of process performance qualification protocols Plan, order, follow up, coordinate and set up of new equipment for the execution of process validations Update documentation: (batch records, SOPs, work instructions)Résultats : Production processes validated Equipment ordered & set-up for validations. Documentation updated and training delivered

Mission:Support, handle and manage the unplanned events generated by the production.Tâches et objectifs : Deviations Management & CAPA Estimation of critical levels based on GMP Impact Analysis, root Causes Analysis, Risks Index Value Estimation Good Documentation Practices/organization to reach deadlinesRésultats : Deviations report (impact, causes) completed CAPA's on-going & Continuous Improvement