Clinical Quality Assurance Auditor

2 weeks ago

Oxford, United Kingdom Qualitas Full time

GCP Auditor - Remote Salary: £60,000 per annum Contract: Permanent Location: Fully Remote (occasional travel for audits) Sector: Quality Assurance / Clinical Research About the Company Our client is an international QA consultancy renowned for delivering expert GxP auditing services across the life sciences sector. Partnering with leading pharmaceutical, biotechnology, and CRO organisations, they provide trusted, independent auditing solutions across GCP, GLP, and GDP. Due to continued global growth, they are seeking an experienced GCP Auditor to join their expanding team. The Role As a GCP Auditor, you'll play a key role in conducting independent audits across global clinical research operations. Working remotely, you'll plan, perform, and report on approximately two audits per month, covering investigator sites, vendors, and internal systems. You'll collaborate with clients to ensure compliance with ICH GCP and applicable regulatory requirements, offering expert guidance and insight. Key Responsibilities Plan, schedule, and conduct GCP audits (investigator site, vendor, system, and internal process). Prepare detailed audit reports and communicate findings effectively to clients. Advise on CAPA development and follow-up to ensure timely closure of audit findings. Support inspection readiness and client training initiatives as needed. Stay current with global GCP regulations and guidance documents. Requirements Minimum 5 years' experience conducting GCP audits independently. Proven background in QA within the pharmaceutical, biotech, or CRO environment. Strong understanding of ICH GCP, EU, and FDA regulations. Excellent communication and reporting skills. Ability to manage time effectively and work autonomously in a remote setting. Willingness to travel internationally for scheduled audits (typically 2 per month). What's on Offer Competitive £60,000 salary (plus expenses). Fully remote role with flexible working. Opportunity to work with an established international consultancy. Professional development and exposure to a wide range of global clients and studies. Interested? If you're an experienced GCP Auditor looking to join a respected international consultancy where your expertise truly adds value, we'd love to hear from you.Apply now or contact us for a confidential discussion. #J-18808-Ljbffr

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