27 ott - 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. This role involves conducting remote, onsite, and questionnaire-based audits, supporting clients across Italy & Europe in meeting regulatory requirements. What You’ll Be Doing Audit 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 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 #J-18808-Ljbffr
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