Senior Quality Assurance Auditor
4 weeks ago
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.
- 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.
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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