We have an immediate requirement for our client based in London for a

Contract Quality Assurance Administrator

Our client is a fully registered clinical trials unit working across one of the top academic institutes in London. They work to deliver world class trials of all phases in various therapeutic areas.

Contract Full time for maximum of three months, (to be agreed).

Brief outline of duties and requirements .

The post holder will support the QA Manager in all aspects of developing, implementing, reviewing and enhancing the Quality Management System (QMS) for the Unit, ensuring that trials are conducted and data processed in accordance with International Council on Harmonisation (ICH) GCP regulatory requirements.

The position will have particular focus on updating of Standard Operating Procedures (SOPs) and Work Instructions for Quality Assurance activities, and ensuring that SOPs followed by the unit are produced, maintained and communicated appropriately.

S/he will also support tracking and implementation of additional activities required to meet requirements of ICH GCP E6 (R2) within the Unit.

Our client is in the process of moving to an electronic QMS, Q-Pulse, and the post holder will assist in implementation activities and documentation as required.

Primary Responsibilities:

• Contribute to the maintenance of an effective Quality Management System
• Review and comment on Departmental SOPs and Work Instructions
• Preparation of SOPs and user guides for the Q-Pulse eQMS, based on generic documents
• Assist the QA Manager with implementation activities for the Q-Pulse eQMS
• Assist the QA Manager with follow up on corrective and preventive action plans and gap analyses.

• Assist with the management of the Quality System to ensure maintenance of SOPs and Work Instructions (WIs), including version control, QC review, publishing, revisions and archiving
• Assist the QA Manager with authorship of SOPs covering the Quality System, Q-Pulse or general activities.
• Support the QA Manager with the review of SOPs for adherence to ICH GCP, regulatory requirements, current best practice and Sponsor SOPs.
• Ensure personnel are notified about SOPs and WIs relevant to their role
• Track reading of SOPs and WIs across the Unit, and escalate non-compliance to management as appropriate
• Review and log SOP deviations and agree corrective/preventative actions
• Support the QA Manager with the management of corrective and preventative action plans to address findings and observations from audits and internal sources, and support ICTU personnel to ensure appropriate actions implemented
• Assist the QA Manager with preparation of presentations
• Assist the QA Manager with preparation and update of user training material for the Q-Pulse eQMS
• Provide routine system administrator support to the Q-Pulse system such as document upload, configuration and user account management.

You should recognise yourself here

• A degree qualification or equivalent in a science or health related field

• Previous experience of Quality Assurance, preferably within a clinical trials unit
• Experience of working within a regulated environment, (GCP, GLP or GMP)
• Experience of document management and version control
• Experience in authorship and review of Standard Operating Procedures (SOPs)
• Knowledge of clinical trials in all phases
• Experience of maintaining a Quality Management System
• Experience in use of Q-Pulse, or similar Quality Management System
• Experience in defining process diagrams

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