PrecisionMedicineGroup

1,001-5,000 employees
119 jobs posted

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PrecisionMedicineGroup

GCP Auditor

Added

19 days ago

Location

🌍 Europe

Type

Full time

Salary

Salary not provided

Related skills

gcp edc ich ctms capa

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📋 Description

Support the Quality Management System including SOPs, training and CAPA
Process and maintain documentation for controlled documents
Develop and administer training for employees and/or consultants
Host client/sponsor audits and support regulatory inspections
Coordinate and conduct vendor, internal, investigator site & TMF audits
Participate in computer systems validation and change control

🎯 Requirements

Extensive knowledge of GCP/CRO/vendor audits in clinical trials
GCP/ICH guidelines and FDA regulations knowledge
Bachelor's degree in science/healthcare or equivalent
Travel up to 25% domestically and internationally
2+ years QA GCP experience
Experience with electronic trial systems (EDC/CTMS/IxRS/ePRO)

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