GxP Auditor (remote-based)
- Experience Level
- Experienced (non-manager)
Hobson Prior are working with an award-winning, data-focused CRO who are looking for an GxP Auditor to join them on a permanent basis.
Please note that to be considered for this role you must have the right to work in this location.
- You will develop quality-related documentation for client projects, including SOPs, work practices, forms, training materials, etc.
- Support with Project Management activities associated with auditing projects, including maintenance of project information.
- You will oversee and follow to applicable regulatory and legal requirements, including all applicable policies, procedures, and training requirements.
- Cooperate directly and with clients and demonstrate strong client interaction skills.
- You will plan, prepare and conduct GxP audits, including investigator site, vendor qualification, process, quality system, computer system and other types of clinical trial and pharmaceutical-related audits as required.
- Develop audit documentation as required.
- Organise and perform peer reviews and finalization of documents according to project timelines.
- Resolve Corrective and Preventive Action plans following audit.
- You will support with internal Quality Assurance audits as necessary.
- Develop and maintain SOPs, work practices, forms and other documentation and training materials related to GxP Compliance and Auditing Services.
- Contribute in company and departmental process improvement and recommend suggestions to improve efficiencies.
- Represent self and company in a professional manner and in line with core company values.
- You will practice excellent internal and external customer service, communication, and teamwork.
- You will support objectives and improvement efforts within department and organizationally.
- Capability to travel up both domestically and internationally up to 50%.
- Excellent organizational skills and detail-oriented
- Demonstrated verbal and written communication skills.
- Skilful with MS Office applications.
- Must be able to work independently and to tight deadlines.
- Educated at a bachelor's degree in biomedical, nursing or related life science discipline required.
- Knowledge and application of FDA, OECD, EMA and MHRA Regulations in relation to clinical trials.
- Strong understanding of drug development processes with the ability to apply that knowledge during GxP audits and process evaluations.
- At least 3 to 5 years of related experience or relevant pharmaceutical, health authority and/or CRO experience.
- At least 2 years of experience leading GCP audits.
- Understanding data associated with clinical trials.
- Ability to develop and present SOPs and training materials.
If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.
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