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

qa gcp edc ich ctms

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📋 Description

Support QMS including SOPs, training and CAPA
Manage controlled documents and records
Develop and deliver training for staff and contractors
Host client/sponsor audits and support regulatory inspections
Coordinate vendor, site, and trial master file audits
Provide QA consultation and support to project teams

🎯 Requirements

Extensive experience managing audits in Clinical Trials (GCP, CRO, vendor)
Working knowledge of GCP/ICH guidelines and FDA regulations
Bachelor’s degree in science, healthcare, or related field
Willingness to travel up to 25% domestically and internationally
QA certification preferred (e.g., CQA, SQA)
Experience with electronic trial systems (EDC, CTMS)

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