GCP Auditor
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
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