232 days ago on axepta.ch

Quality GCP Expert -Switzerland

AXEPTA SA

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 Please refer to JobSuchmaschine in your application

Quality GCP Expert -Switzerland

Quality GCP Expert -Switzerland

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

Due to this growth my client is looking for a Quality GCP Expert to join their team on a permanent contract.

 

Responsabilities :

 

  • Plan, schedule and conduct audits of Clinical Investigator Sites, CROs, and Clinical submission documents.

 

  • Coordinate responses and corrective actions from audit findings.
  • Provide GCP advice and support to the company’s Clinical Operations and other departments
  • Assist in the review and revision of Clinical Development and QA SOPs.
  • Conduct GCP training
  • Alert QA GCP Management of internal and external GCP compliance and clinical trial issues in a timely manner.
  • Provide support for regulatory authority inspections including conducting pre-inspection audits of sites.
  • Assist with the management of QA consultants performing audits

 

Requirements

 

  • Bachelor’s degree
  • 5 – 10 years’ experience in a pharmaceutical or bio-pharmaceutical company in a GCP QA role in an international environement
  • At least 5 years’ experience with GCP audits of CRO’s and investigator sites.
  • Able to travel up to 40% at international level
  • Strong written and oral communication skills.

Please contact Noemie Oliva at noliva@axepta.com for more information