As an Aseptic Operations Expert you are responsible for ensuring that the aseptic practices/activities in place in the Fill & Finish department are in compliance with relevant GMP. Definition and implementation of the APS (Aseptic Process Simulation or Media Fill) strategy on aseptic production lines: ensure on the floor oversight and organization of each APS in compliance with GMP rules and procedures in force. Elaboration and drafting of the operational documentation required for the successful completion of APS activities (Risk Assessments, Protocols, Reports, Annual Plans, etc.).Collaboration in the organization, management and execution of air flow visualization studies (AVS or "smoke tests"): definition of strategy, drafting of related operational documentation, supervision of the activity.Observing the aseptic behavior of production operators, to ensure the quality of aseptic operations carried out by those involved in the aseptic core.Carrying out training courses on good practice/aseptic behavior for staff working in the aseptic core.Management of deviations, CAPA, Change Control within the scope of activityRepresent your activity in the event of regulatory audits/inspections (EMS)Participation in assessing compliance with current regulatory requirements (Annex 1 EU GMP, FDA Guidelines etc.) and future updates, assessing any gaps and guiding the implementation of identified best practices Who you are: Education in biotechnology, or equivalentMastery of the pharmaceutical environment and in particular of aseptic filling processes and aseptic practices (3-6 years experience)Knowledge of Good Manufacturing Practices (BPF / GMP), in depth knowledge of Annex 1 EU GMPEditorial quality (Procedures, risk analyses, deviations, etc.)Team spirit, leadership, autonomy, proactivity, and good communication are qualities necessary for successFrench mother tongue/fluent – Good level of English (minimum B2)