Senior QA Auditor - GCP & CSV Compliance Lead

hVIVO Services Limited; Harlow; Híbrido; GBP 50.000 - 75.000; Jornada completa

Descripción de la vacante

hVIVO Services Limited is recruiting a Quality Assurance Auditor/Senior Auditor - GCP and CSV, based in Canary Wharf, London. The role is permanent and site-based 2–3 days a week, focusing on audits of processes, facilities, studies and supplier QC against GCP/CSV regulations.

You will plan, conduct and close audits, ensuring adherence to QMS and regulatory requirements across internal and external audits, with involvement in sponsor and regulatory inspections where required.

Formación

• Auditing suppliers, vendors, clinical sites and laboratories.
• Auditing and validating systems.
• Excellent knowledge of GCP and GCP for laboratories regulatory standards.
• Working knowledge of GLP and GMP standards.

Responsabilidades

• Plan and conduct audits of processes, systems, facilities and studies to verify compliance and effectiveness of quality systems.
• Conduct remote audits of low to medium risk suppliers and subcontractors.
• Conduct on-site audits of high-risk suppliers.
• Close out audits and agree corrective actions with auditees.
• Maintain up-to-date knowledge of regulations and SOPs.
• Lead external audits and regulatory inspections support.

Conocimientos

Auditing suppliers/sites

Systems auditing

GCP/GCP for labs

GLP and GMP knowledge

Strong communication

Problem solving

Attention to detail

QA auditing experience

Descripción del empleo

hVIVO Services Limited is recruiting a Quality Assurance Auditor/Senior Auditor - GCP and CSV, based in Canary Wharf, London. The role is permanent and site-based 2–3 days a week, focusing on audits of processes, facilities, studies and supplier QC against GCP/CSV regulations.

You will plan, conduct and close audits, ensuring adherence to QMS and regulatory requirements across internal and external audits, with involvement in sponsor and regulatory inspections where required.