GCP Auditor

Direct message the job poster from Nexia

Role Overview

We are seeking a skilled GCP Auditor to ensure our clients' clinical trials meet the highest regulatory and quality standards. You will plan, conduct and report on GCP audits across investigator sites, suppliers and internal processes, manage CAPAs, and support inspection readiness activities. This role requires strong GCP knowledge, excellent communication skills and the ability to work independently in a fast-paced environment.

Key Responsibilities

• Conduct GCP audits (site, supplier, internal) and prepare clear, concise reports.
• Manage CAPAs through to closure and track compliance trends.
• Contribute to risk-based audit planning and quality process improvements.
• Support regulatory inspection readiness and participate in inspections.
• Collaborate with cross-functional teams to ensure compliance and best practice.

Requirements

• Degree in Life Sciences, Quality or related field.
• Strong experience in GCP auditing and regulatory compliance.
• Solid understanding of ICH GCP and relevant global regulations.
• Excellent communication, analytical and organisational skills.
• Ability to work independently in a remote setting.

Preferred

• Experience with other GxPs (GCLP, GVP) and global clinical trials.

• Seniority level
  
  Mid-Senior level

• Employment type
  
  Full-time

• Job function
  
  Quality Assurance, Science, and Research
• Industries Biotechnology Research and Pharmaceutical Manufacturing

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