- gestion des formations du personnel de production- gestion documentaire

Staff training: Create training support according to training needs Carry out training in different fields and with different audiences: - BPF / HSE / training in batch procedures and records / OPI / calculations - All staff, all departments Record trainingEvaluation Training support update (continuous improvement)Operational quality assurance: Manage field problems Open deviations and carry out field investigations Review batch files for the release of bulk products Quality assurance: Manage deviations, complaints, CAPA (Correct Actions - Prevent. Actions) and Change control Carry out self-inspections and quality audits :- Prepare audits, in accordance with GMP standards / iso22716 / iso13485 - Audit different sectors, write report and propose CAPA Carry out APR (Annual Product Review) : - Extract production data and quality control - Analyze trends Document management: Write or approve SOP (standard operating procedure) and MBR (Master Batch Records)Validation and qualification: Review protocols and reports for validation and qualification of equipment Conduct cross-functional projects: Lead projects (new machines, new products) Quality control: Carry out analyzes of routine (dosage, pH, density) Conclude on the conformity of the products analyzed with respect to the specifications

Deviation management :Root Cause Investigation (RCI)CAPAs implementationCompliance officerqualificationPQR writting : data analysis (using statistical software minitab)SOP improvement and approvalField :Biotechnology / monoclonal antibodies manufacturing / sterile API

Quality control: Perform routine analyzes on sterile radioactive medication (HPLC) respecting the safety rules related to the handling of radioactive products Production: Planning deliveries Quality assurance: Release of sterile radioactive drugs

Context and mission : Problems occurred during scale-up and scale-down.Literature search :Hydrodynamic and scale transfer studies Experiments :Experimental design for oxygen transfer and mixing time modellingUse of 5L to 1000L bioreactorsWorking under GMP standardsStatistical data analysisTraining of 2 techniciansResults: Tool creation to determine operating conditions in order to optimize production and facilitate scale-up ad scale-down of cell culture processes.

Context and mission : Discovery of a new species of Enterococcus in mouse gastro intestinal tract. Experiments : - Bacterial culture in various operating conditions - Design of primers to perform sequencing - Use PCR, DNA extraction and gel electrophoresis techniques Results: Phenotypic and genotypic characterization of Enterococcus. Genome publication.

Context and mission : Basic research: understanding of interactions between soil and microorganismsLiterature search :- Study of conjugation and gene transferExperiments :- Culture of filamentous bacterium (Streptomyces) in liquid and solid mediaResults : Protocol implementation to highlight horizontal gene transfer between bacterium.This protocol will be used to study soil compounds influence on Streptomyces evolution.

Accueil patients :Accueillir les patients, ėtablir une relation de confianceVėrifier la recevabilité de la prescriptionContrôler les modalitės de délivrance spėcifiques de certains mėdicamentsRepérer les interactions médicamenteuses, les contre-indications et contacter le prescripteur si nécessaireDélivrer les médicaments au patient ou au personnel soignant et informer sur les modalités de la prescriptionS'assurer de la bonne compréhension du traitement par le patientSanté :Participer aux soins de premiers secours : conseil pharmaceutique , orienter vers d’autres professionnels de santé si nécessaireParticiper aux actions de santé publique, de dépistage, de préventionStup :Réaliser les opérations administratives et le suivi de délivrance des médicaments dans l’ordonnancier, le registre des stupéfiantsVérifier à chaque début de mois le stock des stupéfiants et éditer la balance des stupéfiantsGestion des stocks :Vérifier la conformité de la livraisonRéaliser un inventaire de l’ensemble des stocks (CT)Commander les médicaments et produits de santé aux grossistes, laboratoiresRéceptionner les commandes (CT)

Context and mission: Study of an enzyme responsible for antibiotic resistances in microorganisms. Experiments : - Molecular modelling - In silico mutations - Study of aminoacids protonation in the active site with PROPKA (software) Results: Suggestion of a reaction mechanism of antibiotic degradation (b-lactamines) by b-lactamases.