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Senior QA Auditor - GCP Clinical Trials, London
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Client:
hVIVO
Location:
London, United Kingdom
Job Category:
Other
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EU work permit required:
Yes
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Job Reference:
37aa666f47ce
Job Views:
14
Posted:
28.04.2025
Expiry Date:
12.06.2025
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Job Description:
Overview
hVIVO would like to recruit a Senior Quality Assurance Auditor. This is a permanent position based in E1 and E14, London, and is site-based 2 or 3 days a week.
The main purpose of the role is to ensure that hVIVO complies with relevant SOPs, regulations, and internationally recognized guidelines (including Statutory Instrument 2004 No. 1031 and its amendments, ICH GCP, and GCP for laboratories). The role also involves conducting audits of all systems, processes, facilities, documents, and studies within hVIVO, as well as of suppliers and subcontractors, to deliver the audit program as required by GCP.
hVIVO conducts human challenge studies offering services to pharmaceutical and biotechnology companies, using various clinical trial methodologies across different viral challenges. The goal is to eradicate or ease treatment of illnesses like the cold and flu. Volunteers are central to our work, and our studies focus on testing new treatments on real people in a safe, controlled environment.
Main Responsibilities
* Plan and conduct audits of hVIVO processes, systems, facilities, studies, and documents including protocols, reports, and validation documents, ensuring compliance and effectiveness of quality systems within scheduled timelines.
* Audit low to medium risk suppliers and subcontractors remotely.
* Audit high risk suppliers onsite.
* Follow up and close all audits, agreeing on corrective actions with relevant staff.
* Assess compliance with the hVIVO QMS and ensure actions are followed up.
* Maintain knowledge of current regulations, guidelines, and SOPs.
Internal Audits
* Prepare for audits by reviewing previous reports and relevant legislation.
* Develop audit plans detailing scope.
* Conduct audits by reviewing documentation and observing procedures.
* Assess and categorize findings.
* Present findings in close-out meetings and produce audit reports.
* Conduct peer reviews of audit reports.
* Follow up on audit responses and assess corrective actions.
* Review SOPs and Master Forms as part of the QA process.
Audits of Suppliers and Subcontractors
* Conduct remote and onsite audits, assessing supplier compliance.
* Compile relevant questions for compliance assessment.
* Decide on supplier suitability and update approved suppliers list.
Hosting External Audits
* Assist with external sponsor audits and inspections.
* Manage documentation and responses required during audits.
Compliance & Training
* Maintain knowledge of industry regulations and standards.
* Attend external training and share insights.
* Train and assess QA staff.
Skills & Experiences
* Experience auditing suppliers, vendors, clinical sites, and labs.
* Strong knowledge of GCP and GCP for laboratories standards.
* Knowledge of GLP and GMP standards.
* Excellent communication skills.
* Attention to detail and problem-solving skills.
* Experience in pharmaceutical or CRO environments.
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