Quality Auditor

Our global pharmaceutical client based in Moorgate, London has an exciting opportunity for an experienced QA professional to join their Global Development Quality group as a temporary contract Quality Specialist for initially up to 6 months, with a possible extension.

This role will expose you to the full range of investigational medicinal products in the development pipeline, from simple small molecules through to complex immunotherapy treatments, and a chance to make a real difference to patients receiving these lifesaving and life changing medicines.

As a Quality Specialist, you will be responsible for the final review of clinical batch records to ensure compliance with GMP and conformance with regulatory filings. The compilation and approval of this data pack and presentation to the QP for final release is the core function of the role, and you will work closely with global functions supporting the clinical supply chain, as well as clinical manufacturing sites internally and externally around the world to help you achieve this. Our client is therefore looking for excellent communication skills, an ability to manage issue resolution, confidence to work with minimal supervision, and a keen eye for detail. Our client offers hybrid working with an hourly rate of £18.00 - £29.39 per hour, depending on experience plus 25 days holiday pro rata and other benefits.

Duties include:

• The Quality Auditor conducts routine audits of data, information, procedures, equipment and systems (including computer systems), and/or facilities to ensure the compliance with SOPs and GMPs and worldwide regulations.
• Review and approve production and analytical documentation accompanying the release of API, Safety Assessment or clinical supply lots (bulk and packaged) to ensure conformance to appropriate regulatory requirements.
• In addition, the Auditor communicates and resolves audit comments with client areas.
• Under supervision, or as part of a team, perform audits or inspections of assigned areas or systems to assess compliance with regulatory and Company standards.
• Issue reports summarising deficiencies and work with areas to execute remedial action.
• Notify appropriate management of inspection result.
• Works with moderate work direction and is skilled and knowledgeable to the position.

Experience, Skills, Knowledge and Qualifications:

• Experience should be in the pharmaceutical/chemical industry or government drug-regulatory agency with a working knowledge of cGMP regulations.
• Effective communications (oral/written) and interpersonal skills are necessary.
• Ideally you should have existing experience in a QA or similar role in a GMP environment, however our client would be just as interested in new science graduates (Bachelor’s degree minimum) with the right attitude and a willingness to learn.