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Rbw Consulting Limited
,
London, Greater London
Quality Assurance GCP Specialist / Manager. 6 Month Contract Pharma
Overview
Quality Assurance GCP specialist / Manager.6 Month Contract – Pharma. To support our small, start-up Pharma client, I am now recruiting for a GCP focused Quality Assurance specialist to join the team, on a contract basis, for approx. 6 months. As our client plans their first clinical trials, this role will see you providing crucial input towards the set up and maintenance of a QMS / Quality Management System and SOPs in accordance with the study plans.Initial task will involve - · Developing GCP/ICH systems and SOPs to set the quality of clinical trial(s) activities. · Performing reviews of trial protocols and other documentation (including CRFs and Informed Consent Documents, CRFs) · Establishing working practices with CROs to set quality agreements and ensure quality standards are met. · Establishing TMF or hosted TMF services. · Setting up internal Quality Audit procedures, CAPA, Quality Management Review processes. The ideal candidate will be flexible to visit our clients office in London when required with remote working possible at other times. Viewed as Outside IR35 by client. If you have strong GCP QA experience, especially in setting up systems and processes in for a new company / department, then please get in touch with me - Simon Penrose via the contact details aside, to discuss this project in more detail.