R&d Analytical Development Scientist I

hace 3 meses

León León provincia, España PCI Pharma Services A tiempo completo

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.

We are PCI.

Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

Funciones:
El Técnico Jr de Desarrollo Analítico, bajo la dirección del Supervisor del Departamento y reportando al mismo y con el soporte del Técnico Sr, es la persona que lidera los proyectos del departamento a través de la investigación bibliográfica y evaluación de los métodos analíticos a transferir desde los laboratorios del cliente, optimización y/o desarrollo (tanto para proyectos propios o de cliente). Así mismo, es el encargado de preparar los protocolos de Transferencia o Validación de los métodos analíticos y de los informes asociados a ellos, todo ello con la normativa aplicable en vigor (GMP, FDA, etc) y a los procedimientos internos de la compañía.
- Elaboración de protocolos de transferencia y validación de métodos analíticos así como de los informes correspondientes.
- Desarrollo y/o optimización de métodos analíticos nuevos o ya existentes.
- Gestión, organización y supervisión de los Analistas de Desarrollo Analítico asignados para la ejecución de las actividades experimentales así como soporte a nível técnico de los mismos y del personal en formación.
- Revisión de la documentación generada por los Analistas de Desarrollo Analítico y evaluación de datos, estudio de tendencias
- Comunicación con el cliente.
- Verificación de nuevas monografías USP, EP
- Participación y sorporte en los eventos de calidad (OOS, OOT, Desviación, Controles de Cambios, CAPA’s, inicidencias, reclamaciones y otros eventos de calidad que apliquen) así como elaboración y/o revisión de Especificaciones, Procedimiento de Análisis, requerimientos especiales y otros procedimientos de Laboratorio o relativos.
- Soporte analítico para la preparación de la documentación técnica del producto: TIP, DMF,CTD, DL.
- Colaboración con el departamento de Control de Calidad en la evaluación para la adquisición de nuevos equipos así como en las propuestas de calibración, verificación y mantenimiento de los mismos.
- Colaboración con el departamento de Control de Calidad en la gestión, organización y limpieza del laboratorio.
- Participación en auditorías internas y externas (de clientes o autoridades sanitarias competentes).
- Desempeñar sus funciones siguiendo los criterios de calidad, las normas de seguridad e higiene establecidos por la compañía.
- No es necesaria experiência.

Join us and be part of building the bridge between life changing therapies and patients.

Let’s talk future

Equal Employment Opportunity (EEO) Statement:

- PCI Pharma Services is an Equal _Opportunity/Affirmative_ Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status._
- At PCI, Diversity, Equity, and Inclusion (DEI) are at the core of our company’s purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture._

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