27 ott - Romano di Lombardia
RRxCo.
About the RoleRRxCo are expanding our global auditor network and seeking experienced GCP Auditors to deliver high-quality, risk-based audits across the pharmaceutical and life sciences sector.Se desidera conoscere i requisiti per questo ruolo, continui a leggere per trovare tutte le informazioni pertinenti.This role involves conducting remote, onsite, and questionnaire-based audits, supporting clients across Italy & Europe in meeting regulatory requirements.What You’ll Be DoingAudit PreparationDevelop audit agendas from pre-qualification dataAlign scope with RRxCo and client stakeholdersCoordinate audit logistics with auditees and clientsReview key quality and compliance documentationAudit DeliveryConduct GCP audits of investigator sites, Clinical Systems (QMS, TMF etc.), CROs and other Vendor audits.Perform audits onsite, remotely,
or via desktop assessmentAssess compliance against but not limited to:FDA, MHRA, EMA Regulations21 CFR part 1121 CFR part 16Protection of Human Subjects21 CFR part 31221 CFR part 314ReportingDeliver draft audit reports within 5 working daysParticipate in debriefs where requiredFinalise clear, high-quality audit reports addressing all feedbackWhat We’re Looking ForExpert knowledge xysqume of Global GCP regulationsAbility to work independently and manage global stakeholdersExperience with remote and international auditsWillingness to travel globally when neededWhy Join RRxCo?Work with a global client portfolioBe part of a trusted network of GxP expertsOpportunity to support impactful compliance initiatives worldwide#J-18808-Ljbffr
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