17 oct
|
RRxCo.™
|
Madrid
Consultant GCP Auditor (Europe) – Contract
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Location:
Europe
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Company:
RRxCo
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Engagement:
Contract / Project-Based
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Work Type:
Onsite / Hybrid
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
- Proven experience delivering
GCP audits in pharma/biotech
- 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?
- Flexible, project-based engagements
- Work with a
general client portfolio
- Be part of a trusted network of
GxP experts
- Opportunity to support impactful compliance initiatives worldwide
📌 GCP Auditor (Madrid)
🏢 RRxCo.™
📍 Madrid