R&d Process Development Scientist Ii

hace 4 meses

Gijon, 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.

El técnico de Desarrollo Galénico (Scientist II) se encarga, bajo la dirección del responsable y el supervisor del departamento, del desarrollo de la formulación del producto, implementación y optimización de los procesos de fabricación. Desarrolla su función de acuerdo con las normas GMP y FDA aplicables al mercado al que se dirija el producto, así como a los criterios de calidad y a los procedimientos internos de la compañía.
- Realización actividades de desarrollo de nuevos productos y transferencia de productos a nível de fabricación:

- Desarrollo de formulación.
- Evaluación técnica de la documentación en procesos de transferencia.
- Desarrollo de proceso y adaptación de los procesos a la planta de acuerdo con la normativa GMP, FDA e ICH.
- Evaluación de los materiales de partida de acuerdo con las farmacopeas de los mercados a los que es destinado el producto.
- Comunicaciones técnicas con clientes.
- Redacción de guías de fabricación y revisión de guías ejecutadas durante la fase de desarrollo hasta la propuesta comercial una vez validado el proceso, y seguimiento de dichos procesos de fabricación.
- Trasferencia de los procesos validados al departamento de Producción y soporte si fuera necesario.
- Redacción de estudios de soporte y documentación asociada a los lotes de registro (por ejemplo: estudios de compatibilidad de materiales, estudios de estabilidad, estudios de caracterización, estudios de holding time, análisis de riesgos).
- Participación en las actividades de registro de nuevos productos.
- Redacción de documentación asociada a los lotes de validación de proceso (por ejemplo: protocolos e informes de validación de proceso).
- Formación, al personal de fabricación, en los procesos desarrollados.
- Redacción, actualización y revisión de procedimientos de aplicación a desarrollo galénico.
- Participación en la redacción, actualización y revisión de procedimientos de planta relacionados con su ámbito de competencia.
- Iniciación, investigación y participación en las acciones de los eventos de calidad detectados en los proyectos asignados: desviaciones, controles de cambios, acciones correctivas y preventivas, reclamaciones, rechazos y otros eventos de calidad que apliquen.
- Participación en auditorías internas y externas (de clientes o autoridades sanitarias competentes).
- Gestión, organización y supervisión de las actividades del personal del laboratorio de desarrollo galénico.
- Formacióndel personal en formación.
- Desempeñar sus funciones siguiendo los criterios de calidad, las normas de seguridad e higiene establecidos por la compañía.
- Tener menos de tres años de experiência en el puesto.
- Nível de ingles fluido hablado, escrito y leido

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._

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