Upsilon Global are seeking a freelance GCP Auditor in Spain to support EMA clinical site inspection preparation on behalf of a USA-based CRO.
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This assignment is linked to an upcoming EMA submission, with a focus on inspection readiness. The sites are based in the US, with one site in Spain.
The ideal profile will have GCP auditing experience, strong knowledge of inspection readiness activities, and be based in Spain.
Responsibilities:
* Plan and conduct assigned audits
* Perform for cause audits as needed
* Write and issue audit reports, ensuring clear communication of audit findings to auditees and management
* Review responses to audit findings for appropriateness and completeness
* Close assigned audits
* Develop CAPAs as appropriate. xpzdshu
* Prepare for and host/support Regulatory Authority Inspections
* Write/review/revise QA SOP/WI
* Provide guidance to staff/management on quality related matters
* Contribute to creation of company QMS
* Apply critical thinking to identify solutions to non standard requests, issues and problems
* Require minimal instructions on day to day assignments
* May review vendor audit reports
* May provide coaching/training to company or vendor personnel
This project may start before the end of April.
For more details please apply, contact Janet Kruger or email