randstad candidatos ofertas de empleo volver Regulatory Affairs Technician (MOD 3)

Regulatory Affairs Technician (MOD 3) en Sant Celoni, Barcelona.

14 Sep 2021 publicado por Professionals

company
tipo de contrato
Temporal
jornada laboral
Completa
sector empresa
Química Farma
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puesto
técnico registros
vacantes
1
localidad
Sant Celoni
provincia
Barcelona
especialidad
Life Sciences
subespecialidad
Pharma y Biotech - Medico
modalidad
Presencial
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our client

Our client, an important pharmaceutical laboratory, requires the incorporation of a RRAA technician to carry out the following functions:

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.

your functions

·       Writing and reviewing of regulatory variation record cards, variation dossiers, complete parts of Module 3 or other additional documentation related to products manufactured in the facory.

·       Review of technical documentation

·       Regulatory compliance for existing dossiers

·       Dossier compliance verification of analytical methods, manufacturing instructions and other related documents.

·       Write and manage renewals for site drug products and for site registration

·       Organization/assistance to meetings with the suitable people involved in the writing of a regulatory dossier. Manage of documentation related to quality assurance

position requisites

- Degree in Chemistry / Pharmacy / Biology

- Master¿s Degree in Pharmaceutical industry 

- Excellent level of English and Spanish, spoken and written

- Experience in Mod. 3

  • Formación: Licenciado: Farmacia
  • Conocimientos: registros farmacéuticos
  • Experiencia: 1 año
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