Quality Auditor

Location: Shoreditch

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 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.

We are 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 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 1 mandatory day in the office which may increase to 2 days a week in the future. This role pays hourly rate of £18 - £26.50 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.

* Communicate 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 summarizing 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:

* Ability to demonstrate experience in the pharmaceutical industry or government drug-regulatory agency

* Working knowledge of cGMP regulations.

* Good attention to detail.

* Effective communication (oral/written) and interpersonal skills.

* Self-motivated.

* Able to lead and contribute as a team player and able to manage, prioritise and deliver on multiple projects and tasks.

* Advanced problem solving and proficient decision-making skills.

* Should be proficient in use of Microsoft applications and be able to learn and apply use of software for day-to-day GMP activities.

* Bachelor’s degree in science in any of the life sciences or related relevant discipline.

* Minimum of 3 years applied professional work experience in Quality roles within pharmaceutical industry