GMP Auditor

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

Office based, North West, United Kingdom

PURPOSE:

An exciting opportunity has arisen for an experienced GMP Auditor to join Acceler8 Clinical Research, a fast-growing global, full-service clinical research organisation (CRO). The role offers the opportunity to work within a dynamic, international CRO. This varied and exciting role allows the successful candidate the opportunity to develop and grow within our expanding company, supported by an enthusiastic and knowledgeable team.

The GMP Auditor is responsible for the planning and conduct of GMP audits. Experience in management of Quality Management System (QMS), implementation and maintenance will be highly regarded.

ROLE:

• Interpreting laws, regulations and Acceler8/Sponsor policies on its relevance for project execution
• Analysing present compliance status of QMS documents and related processes
• Gap analysis against regulations and internal requirements
• Defining and supporting projects to implement best practices
• Participation in internal and external projects
• Provide training and act as certified trainer
• Analysing and advising Business Development team
• Set up proactive and requested meetings with customers to determine the requirements of a request and to define the scope of a project or a process change request
• Analysing compliance status of documents and related processes, perform and support gap analyses and risk assessments
• Liaise with staff about gap analysis and advice upon possible solutions at all levels of the Acceler8/Sponsor organisation
• Analyse compliance problems and provide recommendations to clients
• Present approach and solutions in written and oral reports

EDUCATIONAL AND SKILL REQUIREMENTS:

• Bachelor’s degree, or equivalent, in science
• GMP experience (minimum 2 years) within a pharmaceutical environment, of planning, performing and reporting an audit
• A very strong understanding of the GLP and/or clinical process and experience in managing QMS highly regarded
• Excellent planning/organizational skills and ability to prioritise and multitask.
• Ability to develop effective cross-functional relationships.
• Excellent communication, relationship building and interpersonal skills.
• Able to work with autonomy
• Computer Literacy (Word, Excel, PowerPoint, Outlook Express)
• Numeric and budgeting skills

POSITION REQUIREMENTS:

• Driving license, ability to travel up to 3 days/week when required

BENEFITS

This is an exceptional opportunity to join Acceler8 Clinical Research. Our employees are vital to our success and we are seeking candidates to join our company and grow with us. As a progressive organisation embracing the work/life balance, we offer fantastic opportunities for personal development and advancement as well as competitive salaries, company pension scheme, private healthcare, share options, and life insurance.

PRIVACY NOTICE

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Any offer of employment will be subject to the successful candidate holding the right to work in the UK.

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