29 ott - Bardi
RRxCo.
About the RoleRRxCo are expanding our global auditor network and seeking experiencedGCP Auditorsto deliver high-quality, risk-based audits across the pharmaceutical and life sciences sector.
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This role involves conductingremote, 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 data
Align scope with RRxCo and client stakeholders
Coordinate audit logistics with auditees and clients
Review key quality and compliance documentation
Audit DeliveryConductGCP auditsof investigator sites, Clinical Systems (QMS, TMF etc.), CROs and other Vendor audits.
Perform audits onsite, remotely, or via desktop assessment
Assess compliance against but not limited to:
FDA, MHRA, EMA Regulations
21 CFR part 11
21 CFR part 16
Protection of Human Subjects
21 CFR part 312
21 CFR part 314
ReportingDeliver draft audit reports within5 working days
Participate in debriefs where required
Finalise clear, high-quality audit reports addressing all feedback
What We're Looking ForExpert knowledge xysqume ofGlobal GCP regulations
Ability to work independently and manage global stakeholders
Experience withremote and international audits
Willingness to travel globally when needed
Why Join RRxCo?
Work with aglobal client portfolio
Be part of a trusted network ofGxP experts
Opportunity to support impactful compliance initiatives worldwide
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29 ott - Stezzano
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29 ott - Bari
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29 ott - Bari
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