27 oct
|
RRxCo.™
|
Madrid
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 Europe (Spain, Portugal etc.) 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 integral 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
📌 GCP Auditor (Madrid)
🏢 RRxCo.™
📍 Madrid