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GVP Auditor
Job Posted: 3 hours ago
Salary: £ 45,000 - 60,000 / Annum
Job Type: Permanent
Location: Nationwide
Expire in: a month
Job Description
We're recruiting for a globally respected CRO seeking a UK-based Remote GCP Auditor. This role ensures patient safety and regulatory compliance across international clinical trials through expert auditing of clinical sites, processes, and documentation.
Core Responsibilities
1.
Conduct Risk-Based Audits:
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Lead remote audits of Clinical Investigator Sites, Vendors (Labs, CROs), TMF/eTMF, and Clinical Systems across UK/EU
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Apply risk-based methodologies to prioritize audit targets
2.
Ensure Regulatory Compliance:
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Verify adherence to ICH-GCP, UK Clinical Trials Regulations, MHRA requirements, and GDPR
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Monitor CAPA effectiveness post-audit/inspection
3.
Audit Management:
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Issue detailed audit reports (critical/major/minor findings) via eQMS (e.g., Veeva)
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Maintain comprehensive audit documentation
4.
Support Inspections:
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Host/support MHRA, EMA, and FDA inspections as GCP subject matter expert
5.
Training & Collaboration:
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Deliver GCP training to clinical teams
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Advise on quality issues with Clinical Operations and Data Management
Essential Requirements
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Residency: Must be UK-based with right to work
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Education: Bachelor's/Master's in Life Sciences or related field
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Experience:
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3+ years GCP auditing in CROs/Pharma
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Proven experience auditing Clinical Sites and TMF
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Regulatory Knowledge: ICH-GCP, UK Clinical Trials Regulations, MHRA expectations
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Technical Skills: eQMS (Veeva preferred), MS Office, remote auditing tools
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Language: Fluent English
Preferred Profile
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GCP Auditor certification (RQAP-GCP)
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Experience with risk-based monitoring (RBM)
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Knowledge of ATMPs (Advanced Therapy Medicinal Products)
What We Offer
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Fully remote working within UK
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Competitive salary + performance bonus
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Private healthcare + enhanced pension
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25 days holiday + flexible hours
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Global development programsBefore You Apply
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