Certification & Stability Group Lead

hace 2 semanas

Salamanca, Salamanca, España Merck Gruppe - Msd Sharp & Dohme A tiempo completo
Job Description Buscamos un responsable para liderar un equipo de nueva creación de Certificación/Estabilidad.

Sus funciones se desarrollarán en el marco de Calidad relacionadas con los procesos de Certificación y Estabilidad de la planta de Salamanca, y trabajará en estrecha colaboración con la Dirección de Calidad de la Planta para contribuir activamente en la supervisión de la gestión de la Calidad y procesos de certificación/liberación.

Buscamos una persona con alta motivación y pasión por la gestión de personas, cuyo cometido fundamental será garantizar que las actividades relacionadas con la Certificación y Estabilidad del producto cumplan con las buenas prácticas de manufactura, las políticas corporativas y los requisitos regulatorios establecidos.


Funciones principales del puesto:
Liderar y gestionar el equipo a su cargo: formando, apoyando y evaluando. Garantizar el cumplimiento de las normas de correcta fabricación y políticas internas aplicables. Participación en auditorías regulatorias, internas y autoinspecciones.

Será responsable de las liberaciones/certificaciones de los lotes de producto final de los diferentes IPTs, conociendo las pruebas de producto y el proceso productivo, en estrecha colaboración con el área de Producción y con los QA-IPTs correspondientes.

Será responsable de coordinar la elaboración, revisión y miembro de calidad en procesos relacionados con las actividades de Certificación/Estabilidad del Sistema de Calidad:
eventos, desviaciones, fuera de especificaciones, CAPAs, Controles de Cambio, etc

Formación y experiencia:
Formación universitaria en Ciencias de la Salud.5 años experiencia profesional relevante en el sector farmacéutico.

Conocimiento avanzado en Normas de Correcta Fabricación, Farmacopeas aplicables y de herramientas del Sistema de Calidad*, Gestión de Riesgos para la Calidad y Mejora ContinuaExperiencia demostrable en certificación/liberación de producto.

Experiencia demostrable en participación en proyectos, transferencias y auditorías. Conocimiento avanzado de inglés y español.
Se valorará master en gestión de la industria farmacéutica o similares.

Se valorará experiencia previa gestionando equipos en la industria farmacéutica*Controles de cambios, gestión de desviaciones, fuera de especificaciones, cualificación de equipos, validación de procesos, validación de producto, elaboración de análisis de riesgos, revisiones anuales de producto, reclamaciones, autoinspecciones, etc.


Conocimientos técnicos:
Conocimiento avanzado en los procesos de fabricación de producto, equipos e instalaciones. Se valorará experiencia en la fabricación de productos biológicos y estériles. Conocimiento avanzado en Normas de Correcta Fabricación y Farmacopeas aplicables.

Conocimiento avanzado de herramientas del Sistema de Calidad (controles de cambios, gestión de desviaciones, fuera de especificaciones, cualificación de equipos, validación de procesos, validación de producto, elaboración de análisis de riesgos, revisiones anuales de producto, auditorías, etc.).Conocimiento y experiencia en certificación/liberación de producto.

Conocimiento en gestión de especificaciones de producto.
Conocimiento en revisión e interpretación de dossier de producto.
Conocimiento VICH GL17 y guias Eudralex de la estabilidad de productos farmacéuticos.
Conocimiento sobre transferencia de productos.
Conocimiento medio en herramientas de mejora continua.

Conocimiento en sistema de gestión de materiales y productos:
ERP SAPCurrent Employees apply HERE Current Contingent Workers apply HERE Secondary Language(s)

Job Description:
Search Firm Representatives Please Read Carefully

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities.

All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.

No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place.

Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

RegularRelocation:
VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Not ApplicableShift:

Valid Driving License:
Hazardous Material(s): Requisition ID:R291876

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