Analytical Project Lead
hace 2 días
Su misión principal será coordinar las actividades analíticas necesarias durante todo el ciclo de vida de productos farmacéuticos oftálmicos (pomadas, geles y colirios) desde el desarrollo, transferencia hasta la producción comercial.
Principales responsabilidades:
- Coordinar las actividades analíticas necesarias durante todo el ciclo de vida de productos farmacéuticos oftálmicos en la planta de El Masnou.
- Desarrollo y optimización de métodos analíticos de excipientes, APIs y producto terminado.
- Testing de muestras del desarrollo de formulaciones y productos entrantes (excipientes, API), lotes piloto y clínicos.
- Validación, verificación y transferencia de métodos analíticos.
- Estudios de estabilidad.
- Optimización de los métodos implementados para la producción comercial.
- Soporte al área de control de calidad en la resolución de problemas.
- Supervisión científica de las actividades en el laboratorio y del equipo asignado al proyecto.
- Edición de documentos de soporte necesarios para las actividades (SOPs, protocolos, informes, especificaciones, etc).
- Revisar resultados analíticos derivados de la ejecución de las actividades de desarrollo analítico asignadas y gestionar desviaciones analíticas.
- Definir la planificación del proyecto(s) asignado(s) y asegurar que se cumplen en el tiempo definido.
- Informar sobre posibles desviaciones en tiempo o costes de los proyectos asignados.
- Soporte a las áreas de QC y QA en investigaciones analíticas derivadas de desviaciones, reclamaciones o procedimientos de registro.
- Revisar procedimientos y procesos establecidos dentro del departamento de análisis, proponiendo optimizaciones y contribuyendo al proceso de mejora continua.
- Intervención en la evaluación de nuevos proyectos de productos farmacéuticos de clientes externos.
- Evaluación de métodos analíticos de productos existentes en cuanto al potencial de optimización.
- Colaboración con el departamento de desarrollo de formulaciones, QA, QC, business development y otras funciones de la planta.
- Representación de la compañía en cuestiones científicas y técnicas relacionadas con el desarrollo analítico en reuniones con clientes.
- Transferencia del know-how entre el cliente y Siegfried, así como entre plantas de la compañía.
- Transferir información relacionada con el proyecto asignado a todas las partes interesadas.
- Informar periódicamente al Analytical Development Head sobre el progreso del proyecto(s) asignados, desafíos y bottlenecks.
Educación: BSc, MSc o equivalente en Química, Farmacia, Tecnología Farmacéutica o equivalente.
Idiomas: Idioma del país e Inglés Avanzado.
Experiencia: Mínimo 3 años de experiencia en laboratorios de Desarrollo Analítico, Control de Calidad o similares. Experiencia en gestión de proyectos.
Amplio conocimiento de técnicas analíticas y conocimientos de cGMP.
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