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company_seo_logo Senior Clinical QA Expert

Lugar de trabajo:

Suiza, Vaud, Lausanne

Sector:

Industria Farmacéutica

Función:

Control de Calidad

Fecha última actualización: 29/12/2022

Descripción oferta de empleo

My client is a growing biopharmaceutical company based in the French part of Switzerland looking to expand their quality team.

Due to this growth my client is looking for a Senior Clinical QA Expert to join their team on a permanent contract based near Lausanne.

 

Responsabilities :

  • Provide QA GCP advice and support to Clinical Development/Operations functions and other relevant functions as assigned
  • Plan, schedule and conduct audits of Clinical Investigator Sites, Vendors, Partners/affiliates and Clinical submission documents.
  • Conduct GCP training for internal staff.
  • Assist with the maintenance of the Clinical Quality Management System including QA support for change control, deviations, review/revision of SOPs with ensuring continuous process improvement
  • Coordinate responses and corrective/preventative actions from deviations, audit and regulatory findings.
  • Stay abreast of EU clinical trial requirements, ICH GCP, and guidelines from other regulatory agencies for the management of clinical trials within the EU and other regions, as appropriate.
  • ·Alert Global QA GCP/PhV Management of internal and external GCP compliance and clinical trial issues in a timely manner.
  • Be knowledgeable and be able to understand advanced operational, scientific and/or clinical research areas.
  • Provide support for regulatory authority inspections (or audits by partner) including conducting pre-inspection audits and inspection readiness activities as assigned.

Requirements

  • Bachelor's degree in Science or related discipline
  • At least 2 to 5 years' experience with GCP audits of CRO's and investigator sites.
  • Able to travel up to 30% at international level
  • Strong written and oral communication skills.

Más detalles

Tipo de contrato:Trabajo a tiempo indefinido
Nivel profesional:Administrativo / Oficina

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