Senior Quality Assurance Auditor

4 weeks ago


London, Greater London, United Kingdom hVIVO Full time
About the Role

We are seeking a skilled Senior Quality Assurance Auditor to join our team at hVIVO, a leading provider of clinical trial services. In this role, you will be responsible for ensuring that our quality management systems are in compliance with relevant regulations and guidelines.

Key Responsibilities
  • Plan and conduct audits of hVIVO processes, systems, facilities, studies, and documents to verify compliance and determine the effectiveness of our quality systems and procedures.
  • Assess compliance with hVIVO's Quality Management System (QMS) and ensure appropriate actions are agreed and effectively followed up.
  • Plan, conduct, and follow up audits of suppliers and subcontractors to hVIVO, including remote audits and on-site audits at the suppliers' premises.
  • Act as a Lead Auditor to plan, conduct, and follow up on-site audits of suppliers and subcontractors in line with the supplier audit plan.
  • Assist with external Sponsor audits and regulatory inspections, and manage the back room for Sponsor and regulatory audits.
Requirements
  • Demonstrated experience in auditing suppliers, vendors, clinical sites, and laboratories.
  • Excellent knowledge of GCP and GCP for laboratories regulatory standards.
  • Working knowledge of GLP and GMP standards.
  • Proven communication skills with the ability to communicate with all levels within hVIVO.
  • A pragmatic and diplomatic approach to problem-solving.
  • Excellent attention to detail.
What We Offer

We offer a competitive salary and benefits package, as well as opportunities for professional development and growth. If you are a skilled and experienced Quality Assurance Auditor looking for a new challenge, please submit your application.



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