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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
Mapa
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