Position Description –GMP Auditor
Role:
Full time, part time will be considered
Office based, North West, United Kingdom
Competitive salary
Reports to: Director
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.
Main 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
- Perform risk assessment
- 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 skills 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
We want to reassure you that we take our data protection responsibilities very seriously. By applying for this role you are agreeing to our Job Applicant Privacy Policy and this can be viewed here: https://acceler8clinicalresearch.com/recruitment-privacy-notice/
Any offer of employment will be subject to the successful candidate holding the right to work in the UK.
WE ARE SORRY BUT WE DO NOT ACCEPT APPLICATIONS FROM RECRUITMENT COMPANIES
Please email your CV, together with a covering letter, to enquiries@acceler8clinicalresearch.com
Reference ID: 202609 GMP Auditor – UK