Senior GCP Audit & Compliance Specialist

MMS Holdings Inc; Belfast City District; Presencial; GBP 60.000 - 90.000; Jornada completa

Descripción de la vacante

MMS Holdings Inc is a data-focused CRO seeking a GCP Auditor to join our quality and compliance team in the UK. The role involves planning, conducting, and documenting audits, developing CAPA plans, and monitoring vendors and sites to ensure regulatory compliance.

Occasional travel up to 30% within the UK/EU is required. Ideal candidates will have 5+ years in GCP-regulated environments, strong regulatory knowledge, and proficiency with MS Office.

Formación

• Regulatory and GCP knowledge required.
• Experience planning, preparing and conducting GCP audits.
• Authoring and managing audit documents independently.
• Develop CAPA plans and resolve findings independently.
• Monitor vendors and clinical investigator sites for quality.

Responsabilidades

• Maintain up-to-date knowledge of regulations and guidance relevant to compliance.
• Plan, prepare, and conduct GCP audits independently.
• Author and manage audit documentation with minimal supervision.
• Develop CAPA plans and drive closure of audit findings.
• Monitor vendors and investigator sites to ensure compliance and quality.
• Support other duties within Quality and Compliance as needed.
• Travel up to 30% within the UK/EU for audits.

Conocimientos

Regulatory updates

GCP audits

Audit documentation

CAPA planning

Vendor monitoring

Problem solving

Travel readiness

Educación

College degree or higher

Masters preferred

Herramientas

MS Office

Descripción del empleo

MMS Holdings Inc is a data-focused CRO seeking a GCP Auditor to join our quality and compliance team in the UK. The role involves planning, conducting, and documenting audits, developing CAPA plans, and monitoring vendors and sites to ensure regulatory compliance.

Occasional travel up to 30% within the UK/EU is required. Ideal candidates will have 5+ years in GCP-regulated environments, strong regulatory knowledge, and proficiency with MS Office.