QA TECHNICIAN en PIVOTAL

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QA TECHNICIAN

Fecha de la oferta: 12 Sep.
Empresa que publica esta oferta: PIVOTAL
Ver todas sus ofertas de empleo (2)
PIVOTAL es una CRO (Clinical Research Organization), líder en el sector de Ensayos Clínicos y Consultoría Farmacéutica en España con más de 150 empleados y oficinas en Madrid y Barcelona y empleados en Francia,Italia, Alemania y Reino Unido.

Somos una compañía dinámica, joven y creativa, ofrecemos a nuestros clientes la máxima calidad, excelencia, creatividad y cumplimiento en nuestros compromisos profesionales tanto a nivel nacional como internacional. Nuestro portfolio de clientes cuenta con las compañías farmacéuticas y biotecnológicas más importantes del sector.
Únete al equipo de Pivotal!
Número de vacantes: 1
Provincia/s: Madrid

Descripción

Descripción: Essential job functions:
To provide support to internal Quality Assurance activities as per the following activities:.
• Activities:
o Assist with maintenance of the Quality Management System.
o Supervision of process and procedures to ensure compliance with SOPs, GCP and regulations.
o Assist in preparation, hosting and supporting external audits/Regulatory Authority inspections.
o Assist in performing internal audits and “ad hoc” revisions (vendors, systems, processes, TMF, etc).
o Prepare or review, as needed, quality deviations.
o Follow up CAPAs and maintain tracking tools.
o Provide support for data protection matters.
o Assists in the provision of QA review of Quality Manual documents prior to approval.
o Provide GCP advice/training.
o Raise issues of non-compliance.
o Provide input into process improvement initiatives throughout Pivotal.
o Assist in promoting quality principles in Pivotal.
o Assist in providing internal Quality Assurance consultancy service.
o Perform other related duties that may be assigned as needed.
Edad máxima para el puesto: 65 años.
Tipo de contrato: Indefinido
Remuneración anual: SEGUN VALIA DEL CANDIDATO

Requisitos

Requisitos: O Life science University Degree.
o Previous experience in clinical trials processes and procedures. Previous experience in Quality Assurance desirable.
o Interest in developing personal skills in QA area.
o High level of spoken and written English required (as minimum Advanced level is desired).
o Experience in auditing and preparing inspections is desired.
o Thorough understanding of ICH E6 GCP, applicable national/international regulations, and EMA/FDA requirements
o Willingness to travel at least 30% of the time (domestic and international travel).
o Ability to work effectively across internal departments. Flexibility.
o Ability to investigate and analyze information, to draw conclusions and provide recommendations.
o Detail oriented, accurate and able to solve problems.
o Ability to work in a structured and organised manner.
o Enjoys working as part of a team and independently.

Nivel de estudios mínimo requerido: Licenciado
Idiomas requeridos: Inglés nivel Alto.
Experiencia profesional mínima requerida: 5 años
Disponibilidad para viajar requerida: El 40% del tiempo laboral

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Esta oferta ha recibido 78 inscripciones.