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Quality Officer – Clinical Research

Permanent Position

Paying £35,000 – £45,000 annually

Based in Central London (hybrid role)

Are you knowledgeable in Good Clinical Practice (GCP) with experience in Quality Management System (QMS) documentation?

Would you like to work for a leading clinical research organisation, with a strong pipeline of clinical projects?

My client are a leading clinical and laboratory service provider, specialising in a range of therapeutic areas and with the patient at the heart of their research. Using their specialist clinical trial platform, they play a key role in drug and vaccine development and are currently experiencing an impressive period of growth so are investing heavily in their state of the art clinical facilities in Central London. As a result, they are looking to bring on board a Quality Officer – Clinical Research who will be responsible for managing QMS documentation and the companies eQMS, in addition to leading archiving activities and providing quality advice to those within the organisation.

This is an exciting opportunity to join a leading clinical research organisation within a team of knowledgeable and motivated clinical and quality professionals, driving forward the testing of infectious and respiratory disease products in drug discovery and development.

Key Responsibilities of the Quality Officer – Clinical Research will include;

• Oversee the day to day running of the electronic QMS (eQMS).
• Ensure quality documentation such as standard operating procedures (SOP’s), trial master forms, CAPA’s and company policies are reviewed and stored correctly within the QMS.
• Provide support and advice within the organisation for queries related to quality documentation, archiving and the QMS.
• Act as the company archivist, overseeing archiving activities and ensuring relevant regulatory changes are implemented.
• Support the delivery of internal training related to QMS, archiving and other quality activities.
• Support the quality team with auditing and inspections, both internal and external.
• Ensure adherence to Good Clinical Practice (GCP), implementing continuous improvements to advance GCP compliance and quality within the business.

To be considered for the Quality Officer – Clinical Research role you’ll need the following skills and experience;

• Previous demonstrable Quality / Quality Assurance experience, ideally gained within a clinical research environment.
• Strong working knowledge of Good Clinical Practice (GCP).
• Experience with archiving activities from a regulated environment e.g. clinical research or pharmaceuticals.
• Prior experience reviewing standard operating procedures (SOP’s) and / or computer system validation (CSV) would be strongly beneficial.
• A degree (or equivalent working experience) in a relevant life science discipline such as Biology, Pharmacology, Physiology, Biomedical Science etc.
• Capable of working both independently and within a wider team to ensure the smooth running of the quality function and resolution of associated queries.
• Strong attention to detail and organisational skills, with a thorough approach to maintain quality standards in line with GCP.

Key Words “Quality Officer, Quality, Quality Assurance, QA, Quality Management System, QMS, Standard Operating Procedure, SOP, Archiving, Archive, Regulatory, Continuous Improvement, Good Clinical Practice, GCP, Clinical Research, CRO, Clinical Trial, London, Central London.”

Please apply online or contact Katie-May Kress at CY Partners for more information.