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Gcp/Gvp - Auditor | Porto (M/F)

Michael Page Portugal

14.10.2021 | Porto | Referência: 2031739


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Gcp/Gvp - Auditor | Porto  (m/f)

Referencia: JN -102021-3613663
Adicionado em 14.10.2021
Sobre os nossos clientes
Our client is a reference company in the pharmaceutical industry.

Descriçăo da oferta

Our client is a reference company in the pharmaceutical industry which wants to integrated a QVP/QCP Auditor.

Principais responsabilidades

This person will be responsible for performing audits to ensure compliance of the Clinical, Pharmacovigilance and Medical Affairs Quality Management Systems with applicable legal and regulatory requirements related to company's activities, in accordance with the defined guidelines and goals.

The main responsabilities will be:

  • Comply with the Clinical, Pharmacovigilance and Medical Affairs audits assigned in the Annual Audit Program;
  • Prepare the plan for each audit assigned;
  • Conduct audits according to the competences defined in the approved SQI's Qualification Matrix;
  • Prepare the report and coordinate the response and closing of the respective Corrective Action Plan for each audit conducted;
  • Host Clinical, Pharmacovigilance and Medical Affairs regulatory inspections;
  • Prepare and / or verify SOPs related to Clinical, Pharmacovigilance and Medical Affairs activities, along with other related documentation;
  • Follow Clinical, Pharmacovigilance and Medical Affairs deviations and control of changes generated in QMS.

Perfil desejado

The ideal profile should have:

  • Degree in Health Sciences, Chemistry or similar;
  • Previous work experience in GCP, GVP and Medical Affairs (preferred);
  • Fluency in English (mandatory);
  • Training in GCP, GVP and Medical Affairs audits;
  • Strong computer skills;
  • Availability to make international trips.

Benefícios adicionais

Opportunity to integrate a challenging project.



O que procuramos
GCP, GVP, Quality, Porto, Pharmaceutical
Contacto da Michael Page
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