Qa Automation Engineer — Growth, Impact & Automation

Quantion; Barcelona; On-site; EUR 40,000 - 65,000; Full time

Benefits offered by this job

Remoto ocasional

Contrato indefinido

Job summary

Grifols busca un profesional para un puesto de Calidad en un laboratorio de pruebas de plasma. Se espera supervisión de la documentación, cumplimiento y mejoras en procesos, con énfasis en conformidad regulatoria y gestión de riesgos. Ubicación en Sant Cugat del Vallès, España, con viaje y presencia en sitio.

Se valorará experiencia en entornos regulados, dominio de SOP y habilidades de comunicación en español e inglés. Contrato indefinido y posibilidad de remotos ocasionales.

Qualifications

• Licenciatura en Ciencias de la Vida o campo relacionado.
• 3–5 años de experiencia en un campo relacionado.
• Organizado y capaz de gestionar el tiempo.
• Capacidad para trabajar en un entorno altamente regulado.
• Comprensión de SOPs.
• Capacidad para planificar, comunicar y ejecutar mejoras operativas.
• Alta integridad y compromiso con la Calidad y Cumplimiento.
• Habilidades de comunicación oral y escrita para hallazgos.

Responsibilities

• Revisar y asegurar que todos los procedimientos estén en conformidad con cGMP.
• Supervisar el sistema de calidad y la cultura de calidad del Laboratorio de Pruebas de Plasma GEPD.
• Asegurar que se inicien investigaciones de incidentes y que se realice un análisis de causa raíz.
• Participar y apoyar inspecciones regulatorias internas y externas en los laboratorios.
• Gestionar y supervisar proyectos de Calidad en los Laboratorios de Pruebas de Plasma.
• Participar activamente en reuniones de Laboratorio para seguimiento de cambios abiertos.
• Coordinar las tareas necesarias en las diferentes áreas de la empresa.
• Revisar nuevos procedimientos para implementación en el laboratorio bajo cambios abiertos.
• Garantizar mejoras continuas en los sistemas de calidad de los Laboratorios.
• Supervisar el proceso de Gestión de Riesgos de Calidad (QRM) para los Laboratorios.

Skills

Español avanzado

Inglés avanzado

Education

Licenciatura en Ciencias de la Vida

Job description

¿Te gustaría unirte a un equipo internacional que trabaja para mejorar el futuro del sector de la salud? ¿Quieres contribuir a mejorar la vida de millones de personas? Grifols es una compañía global del sector de la salud que desde 1909 mejora la salud y el bienestar de las personas en todo el mundo. Somos líderes en medicamentos hemoderivados y medicina transfusional y desarrollamos, producimos y comercializamos medicamentos, soluciones y servicios innovadores en más de 110 países y regiones.
**We believe that diversity adds value to our business, our teams, and our culture. We are committed to equal employment opportunities, fostering an inclusive environment where diversity makes us outstanding.**
**Mission**
To review and ensure that all procedures, testing methods and reports established in GEPD Plasma Testing Laboratories are in compliance to Egyptian regulations, and in accordance to cGMP, following Plasma Testing Specifications established and European Regulation. To manage and supervise Plasma Testing Laboratories Quality projects. To propose continuous improvement measures related to the quality systems of the Laboratories. To supervise the Quality Risk Management (QRM) process for the Laboratories.
**What your responsibilities will be**

• To review and ensure that all procedures established are in accordance to cGMP.
• To supervise GEPD Plasma Testing Laboratories quality system and quality culture.
• To ensure investigation for incidents are initiated, as well as root cause analysis are properly in place.
• To participate and support internal and external regulatory inspections and audits performed in the Laboratories.
• To manage and supervise Plasma Testing Laboratories Quality projects.
• Actively participate in Laboratory meetings for the follow-up of activities related to open Change Controls.
• Coordinate the tasks required to be developed within the different areas of the company.
• Review new procedures and processes to be implemented in the Laboratory under the scope of the Change Controls open.
• To ensure continuous improvement measures related to the quality systems of the Laboratories.
• To supervise the monitoring of corrective and/or preventive actions implemented within the Laboratories. Ensure their proper implementation and effectiveness.
• To monitor quality system indicators.
• To propose improvements in the Laboratory's processes to enhance the quality system.
• To supervise the Quality Risk Management (QRM) process for the Laboratories.
• To supervise Quality Risk assessment studies and reports, as well as coordinate mitigation tasks.

**Who you are**
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skills, education, and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions).

• Bachelor's Degree in Life Sciences (Biology, Pharmacy, Biotechnology or related fields)
• Minimum 3-5 years of experience in a related field.
• Organized and able to manage time effectively.
• Ability to work within a highly regulated, labor intensive environment.
• Ability to understand, explain, follow, and enforce SOPs.
• Ability to plan, communicate and execute activities for the improvement of overall operations.
• Strong integrity and commitment to Quality and Compliance.
• Excellent oral and written communication skills to produce clear and concise factual findings.
• Advanced level of Spanish and English.
• This position requires significant travel and on-site presence in Egypt, with approximately 50% of the role based in Egypt.

**What we offer**
It is a brilliant opportunity for you, Grifols is fully aware that its employees are one of its major assets. We are committed to maintaining an atmosphere that encourages all our employees to develop their professional careers in an excellent working environment.
We believe in diverse talent and want to remove any barriers that may hinder your participation. If you require any adjustments in our selection process, please do not hesitate to inform us when applying. We are here to help.
Grifols is an equal opportunity employer.
**Flexibility for U Program** : Occasionally Remote.
**Benefits package**
**Contract of Employment:** Permanent position.
**Location:** Sant Cugat del Vallès. Spain : Sant Cugat del Valles
Type: Indefinido tiempo completo
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