Regulatory Affairs Technician (MOD 3) en Sant Celoni, Barcelona.
14 Sep 2021 publicado por Professionals
- tipo de contrato
- jornada laboral
- sector empresa
- Química Farma
- ver más
- técnico registros
- Sant Celoni
- Life Sciences
- Pharma y Biotech - Medico
- 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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