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Regulatory Technician (fixed term contract for one year) - SANOFI AVENTIS Riells i Viabrea

Publicado por SANOFI AVENTIS Particular 17404, Riells I Viabrea, Girona España

Oferta de empleo como Regulatory Technician (fixed term contract for one year) en SANOFI AVENTIS, Riells I Viabrea, Girona

Publicada el: Wednesday, 11 Sept - 10:04
Nombre de la empresa: SANOFI AVENTIS
Número de trabajadores: 1000

Sede central en: Barcelona

Descripción de la empresa

SANOFI AVENTIS Sanofi es un líder mundial integral de la salud que investiga, desarrolla y distribuye soluciones terapéuticas centradas en las necesidades de las personas y los pacientes.

Sanofi trabaja por y para los pacientes, para proteger y dar respuesta a sus necesidades de salud, así como para mejorar la vida de más de 7.000 millones de personas en todo el mundo.

Nuestra actividad se concentra en las siguientes áreas de especialización: diabetes, oncohematología, trasplantes, enfermedades cardiovasculares, trombosis, enfermedades renales, biocirugía y consumer healthcare (CHC); además trabajamos en otras áreas: Genzyme (Enfermedades raras y Esclerosis Múltiple), Zentiva (línea de genéricos) y Merial (Salud animal).

Estamos presentes en 100 países de los 5 continentes, y tenemos aproximadamente cerca 110.000 empleados en todo el mundo, de los cuales cerca de 1.000 pertenecen a Sanofi Iberia.

Nuestro equipo es nuestro activo más valioso. Por ello, ponemos especial dedicación en todo lo relativo a su desarrollo profesional, a su equilibrio personal-profesional y a su seguridad y salud en el puesto de trabajo. Desde el departamento de Recursos Humanos, nos implicamos en la gestión de personas con un modelo que atrae, acompaña, desarrolla, reconoce y fideliza a nuestros colaboradores.

¡Únete a nuestro equipo! Te ofrecemos un paquete de compensación competitivo acorde al nivel del puesto, una política de desarrollo profesional apoyada por planes de formación específicos, un importante abanico de beneficios sociales y la posibilidad de integrarte en un proyecto sólido y ambicioso en un gran Grupo Multinacional.

Ubicación

Población: Riells I Viabrea
Código Postal: 17404
Provincia: Girona
País: España

Descripción

Puesto vacante: Regulatory Technician (fixed term contract for one year)

Categorías: Sector Farmacéutico - Acceso al mercado y relaciones institucionales

Nivel: Empleado/a
Personal a cargo: (Seleccionar)
Número de vacantes: 1

Descripción de la oferta: This position will be under a fixed term for one year.

About the Opportunity

Writing and/or reviewing of regulatory variation record cards, variation dossiers, complete parts of Module 3 or other additional documentation related to products manufactured in Riells site with suitable quality in the timelines fixed, in coordination with the other services of the plant.

About Sanofi Business Unit

Since 1972, Sanofi Spain has an industrial center in the town of Riells i Viabrea (Girona) located on a land of 50,222m2 and with a constructed area of ​​19,652m2.
The Center belongs to the Division of Pharma Solids EPMM (Established Products Mature Market) - Industrial Affairs of the company and specializes in the manufacture of solid forms (tablets and capsules), as well as being an alternative center for the main products manufactured in other centers of Sanofi. It should be noted that the Riells Industrial Center specializes in the manufacture of the range of thyroid hormones from Sanofi, being the number one producer of this range for the European Market.
The center has 244 employees, according to data from December 2016, year in which 3.165 million galenic units were manufactured, which is equivalent to 69 million units distributed in 73 different formulas for more than 20 different pathologies. Around 5% of the world production of Sanofi comes from the center of Riells. In fact, the percentage of export of production has increased over the last few years: in 2016 85.6% of production was exported, which allowed supplying 120 countries.

Key responsibilities
- Writing and reviewing of regulatory variation record cards, variation dossiers, complete parts of Module 3 or other additional documentation related to products manufactured in Riells;
- Review of technical documentation;
- Regulatory compliance for existing dossiers;
- Dossier compliance verification of analytical methods, manufacturing instructions and other related documents;
- Organization/assistance to meetings with the suitable people involved in the writing of a regulatory dossier;
- Manage of documentation related to quality assurance.

About You

Education:
- Degree in Pharmacy or Chemistry;
- English (good level is a must) and French (recommended).

Experience & knowledge:
- Practical experiences on computers;
- Knowledge in pharmaceutical regulations;
- Experience in writing regulatory variations (recommended);
- Knowledge in drug product, manufacturing process and regulatory dossier of solid pharmaceutical forms;
- Experience in drug product transfers;
- Methodical and practical, analytical thought and synthesis skills.

What Sanofi can offer you
- A role where you are instrumental to creating best practice and as the organisation grows, you can too;
- We offer a generous package including flexible benefits, and are committed to helping you have a healthy work-life balance throughout your career with us;
- We have highly subsidized restaurant;
- Parking available onsite;
- This is a full time role and we support flexible working.

About Sanofi

Empower Life Everyday
At Sanofi we work across human health from vaccines to rare diseases, and consumer healthcare. This creates opportunities to work across different areas to build a diverse and exciting career. Sanofi has the capabilities and resources to support your aspirations to fulfill your ambitions and be the best you can be.
Our purpose at Sanofi is to work passionately every day to understand and solve healthcare needs of people across the world. Our ambition is by 2025, to be a top 3 innovative, global and diversified human healthcare company. One that embraces transformative technologies and is focused on its area of excellence, which means we're not there to try to solve everybody's problems. We want to focus on those areas where we know we are making a difference.
The values we are live by are teamwork, courage, respect and integrity.

Requisitos

Estudios mínimos: Grado
Experiencia mínima: Al menos 1 año
Imprescindible residente en: (Seleccionar)
Requisitos mínimos: Education:
- Degree in Pharmacy or Chemistry;
- English (good level is a must) and French (recommended).

Experience & knowledge:
- Practical experiences on computers;
- Knowledge in pharmaceutical regulations;
- Experience in writing regulatory variations (recommended);
- Knowledge in drug product, manufacturing process and regulatory dossier of solid pharmaceutical forms;
- Experience in drug product transfers;
- Methodical and practical, analytical thought and synthesis skills.

Contrato

Tipo de contrato: De duración determinada
Duración: 1 año
Jornada laboral: Completa
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