Responsable de Estabilidades y Validaciones

¿Quiénes somos? En Salvat, nos conocen por ser una empresa con más de 70 años de historia y líder en ID en España. Fundada en 1955, nuestra sede central se encuentra en Esplugues de Llobregat (Barcelona) y contamos con una filial en Miami (USA). Nos enorgullece ser calificados como “Excelentes” por el Ministerio de Industria, gracias a nuestras plataformas tecnológicas propias y a nuestros centros de fabricación de Barcelona, Madrid y Miami. En Salvat somos un equipo apasionado y comprometido con la innovación y la excelencia. Nuestra cultura se basa en la colaboración, el respeto y el crecimiento personal y profesional. Creemos que cada miembro de nuestro equipo aporta un valor único y, por eso, fomentamos un ambiente inclusivo donde las ideas son bienvenidas y se valoran. ¿Qué buscamos? Stability and Validation Section Manager-Quality Control Department Reporting to the Head of Quality Control Department, the Stability and Validation Section Manager will have following responsibilities: Lead and manage the analytical team that conduct analytical testing of stability studies, analytical method validation, cleaning validation and process validation. Coordination and management of the ongoing stability program and ICH stability studies for the registration of new drug products and support product variations. Review of stability data to confirm shelf life and utilize data analysis and sound scientific rational to establish expiry periods. Prepare documentation of trend analysis reports, and stability summary reports for regulatory submission. Confirmation of atypical and/or out of specification (OOS) results and participation in product investigation by applying root cause analysis and implementing effective CAPAs. Preparation of protocols/reports, coordination and management of analytical method validation/revalidation and method transfer. Application of lifecycle management approach for analytical procedures. Cleaning validation and verifications: Validation of analytical methods, management and coordination of analytical testing of cleaning verification and validation. Process Validation: Supervision and coordination of analytical testing in process validation. Authoring of CMC sections for regulatory submissions and implement regulatory responses to agency submissions. Active participation in external and internal quality audits. Skills and experience: Bachelor’s Degree in Chemistry or Master’s or PhD Degree in Analytical Chemistry. At least 5 years of experience in similar position within the Pharmaceutical Industry. Strong understanding of cGMP and regulatory requirements of markets like EU and US. Extensive knowledge of ICH, WHO and FDA guidelines. Strong technical background in analytical chemistry (UPLC, HPLC, GC, MS, IR) Proficient in trend analysis using statistical software. Demonstrated leadership of technical teams. Demonstrated capability to solve scientific problems. High level of English (B2 minimum).

Location: Esplugues de Llobregat, Catalonia, ES

Posted Date: 8/4/2025