- 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 nivel 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.
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- Participación y soporte en los eventos de calidad (OOS, OOT, Desviación, Controles de Cambios, CAPA's, incidencias, 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.
- Necesaria al menos CUATRO años de experiencia en el sector y posición.
- Nivel de ingles hablado, escrito y leido fluido (B2 o C1 preferentemente)
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R&D Analytical Development Scientist II - España - PCI TRGR Penn Pharmaceutical Services Ltd
Descripción
R&D Analytical Development Chemist II page is loaded
R&D Analytical Development Chemist II
Apply locations Leon, Spain time type Full time posted on Posted Yesterday job requisition id JR109055Life 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.
El Técnico Sr de Desarrollo Analítico, bajo la dirección del Supervisor del Departamento y reportando al mismo, 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 de acuerdo con la normativa aplicable en vigor (GMP, FDA, etc) y a los procedimientos internos de la compañía .
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.
About Us
Why work for PCI Pharma Services?
At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don't say no, we figure out how.
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Usuarios de profesión R&D Analytical Development Scientist II en Madrid
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Angel Gutierrez Cajiao
Supervisor de Laboratorio con HPLC, GC, HPTLC, etc