GCP Auditor

RRxCo.™; Lombardia; Hybrid; EUR 65,000 - 95,000; Full time

Job summary

RRxCo.™ is expanding its global auditor network and seeks 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 and Europe in meeting regulatory requirements, with travel to global sites as needed. You will work independently and collaborate with diverse stakeholders to ensure compliance with GCP regulations.

Qualifications

• Expert knowledge of Global GCP regulations.
• Ability to work independently and manage stakeholders.
• Experience with remote and international audits.
• Willingness to travel globally when needed.

Responsibilities

• 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.
• Conduct GCP audits of investigator sites, Clinical Systems, CROs and vendors.
• Audit onsite, remotely, or via desktop assessment.
• Deliver draft audit reports within 5 working days.
• Finalize high-quality audit reports addressing feedback.
• Participate in debriefs when required.

Skills

Global GCP regulations

Independent work

Remote and international audits

Travel willingness

Job description

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