GMP Auditor — QMS & Training Lead at Global CRO

Acceler8 Clinical Research; Nottingham; On-site; GBP 45,000 - 65,000; Full time

Benefits offered by this job

Company pension

Private healthcare

Share options

Life insurance

Job summary

Acceler8 Clinical Research is seeking a GMP Auditor to join our expanding global CRO. The role focuses on planning and conducting GMP audits, evaluating QMS documents, and supporting improvements across projects with a proactive, cross-functional approach.

Travel up to 3 days per week to client sites may be required; the ideal candidate has GMP experience (2 years), a science degree, strong GLP knowledge and excellent communication skills to liaise with staff and sponsors.

Qualifications

• Bachelor's degree in science is required.
• GMP experience (min. 2 years) in a pharmaceutical environment, planning, performing and reporting an audit.
• Strong understanding of GLP/clinical process and QMS management is highly regarded.
• Excellent planning/organizational skills and ability to multitask.

Responsibilities

• Interpret laws and Acceler8/Sponsor policies for project execution.
• Analyse compliance status of QMS documents and processes.
• Perform gap analyses against regulations and internal requirements.
• Define and support projects to implement best practices.
• Provide training and act as certified trainer.
• Engage with Business Development to advise on requirements and scope.
• Liaise with staff to discuss gap analyses and propose solutions.
• Present findings and recommendations in reports.

Skills

GMP experience

GLP/clinical process knowledge

Planning/organizational skills

Communication/interpersonal skills

Autonomy

Budgeting skills

MS Office (Word, Excel, PowerPoint, …)

Numeric skills

Education

Bachelor's degree in science

Tools

MS Office

Job description

Acceler8 Clinical Research is seeking a GMP Auditor to join our expanding global CRO. The role focuses on planning and conducting GMP audits, evaluating QMS documents, and supporting improvements across projects with a proactive, cross-functional approach.

Travel up to 3 days per week to client sites may be required; the ideal candidate has GMP experience (2 years), a science degree, strong GLP knowledge and excellent communication skills to liaise with staff and sponsors.