27 ott - Romano di Lombardia
RRxCo.™
About the Role
RRxCo 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.
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This role involves conducting remote, onsite, and questionnaire-based audits, supporting clients across Italy & Europe in meeting regulatory requirements.
What You’ll Be DoingAudit Preparation
- Develop 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 Delivery
- Conduct GCP audits of 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
Reporting
- Deliver draft audit reports within 5 working days
- Participate in debriefs where required
- Finalise clear, high-quality audit reports addressing all feedback
What We’re Looking For
- Expert knowledge xbvzest of Global GCP regulations
- Ability to work independently and manage global stakeholders
- Experience with remote and international audits
- Willingness to travel globally when needed
Why Join RRxCo?
- Work with a global client portfolio
- Be part of a trusted network of GxP experts
- Opportunity to support impactful compliance initiatives worldwide
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