Descrizione del lavoro:
Regulatory site officer ż Regulatory technician Evaluate regulatory compliance status of the site. 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
ˇ 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.
ˇ Review of technical documentation
ˇ Regulatory compliance for existing dossiers
ˇ Dossier compliance verification of analytical methods, manufacturing instructions and other related documents.
ˇ Write and manage renewals for site drug products and for site registration
ˇ 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
- Masterżs Degree in Pharmaceutical industry
- Excellent level of English and Spanish, spoken and written.
* Formación: Licenciado: Farmacia
* Conocimientos: registros farmacéuticos
* Experiencia: 1 ańo why with (COMPANY NAME)?
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