Beschreibung

For our partner located in the canton of Neuchâtel, we are looking for:Scientist StabilityStart date:End of mission:Your mission:You are responsible for defining and managing stability programs. You ensure regulatory compliance, scientific reliability of data, and actively contribute to the product lifecycle management.Your responsibilities:- Define and manage product stability programs as a point of contact.- Participate in product transfers to internal or external sites.- Develop and maintain expertise on product stability profiles within the global supply chain.- Design, write, validate, and supervise stability protocols and associated plans.- Manage annual commercial stability programs, in collaboration with teams.- Review and approve stability reports, regulatory sections (CTD), and responses to health authorities.- Contribute to change projects by defining and executing necessary stability studies.- Perform quality impact analyses within the framework of change controls and CAPA management.- Intervene in investigations (OOS/OOT) and analyses related to quality deviations.- Ensure the consistency of stability procedures with internal and regulatory standards.- Participate in internal and external audits.- Represent the stability function during audits and inspections by health authorities.- Collaborate cross-functionally with R&D, Quality, Production, and Supply Chain teams.Your profile:- Higher scientific degree (chemistry, biology, microbiology, or equivalent field).- Minimum 5 years of experience in a pharmaceutical environment, ideally in stability.- Very good knowledge of ICH guidelines (Q1A, Q5C) and cGMP (21 CFR).- Mastery of regulatory requirements (US, Europe, other regions).- Good understanding of drug substance and drug product manufacturing processes.- Experience in technical and documentary writing (reports, regulatory dossiers, protocols).- Mastery of tools: MS Office, LIMS, quality systems (TrackWise, Veeva), statistical tools.- French and English fluent. jidb596d85aen jit0727aen jpiy26aen