Clinical Trials Quality Assurance Auditor

Clinical Trials Quality Assurance Auditor Do you have previous experience in QA auditing within the clinical trials industry and fluent in both Russian and English if so then I would like to hear from you. A new opportunity has become available for a Quality Auditor/Assessor within a leading clinical research organisation. With the choice to work from a variety of European based offices, I am on the lookout for somebody with proven experience in performing quality assurance clinical audits and who is familiar with the relevant ISO standards, ICH/GCP/GMP and regulatory requirements. This role is ideal for someone looking to take that next step forward within their career, and wishing to move into more Project Management role. The successful candidate will help plan and conduct regular and random QA audits assuring compliance with applicable ISO requirements, Good Clinical Practice guidelines, appropriate regulations and applicable guidelines. In addition, your tasks will include: * Ensure that audit results and other quality information are formally and consistently recorded and reported and that corrective actions/preventive actions have been requested and are documented effectively. * Review audit replies to QA. Follow up all outstanding replies and report issues to the relevant management for action. * Assist in creating summary reports for quality feedback and performance measurement. * Perform vendor and sub-contractor audits, as well as validation reviews as required. * Assist with preparation, conduct and follow up of Sponsor and Regulatory audits. * Assist with ISO registration, surveillance audits and follow up. The ideal candidate will be educated in Pharmacy, Medicine or science related discipline with previous experience in QA auditing within the clinical/pharmaceutical industry. You will be proficient in QA procedures and have the ability to review and evaluate various types of systems/processes. It is essential that you are confident in liaising with both departmental and office management and have the ability to speak in both English and Russian. In return you will receive a generous salary and competitive benefits packages, including flexible working hours and much more. For more information please call Kieron Mcdaid at Paramount Recruitment on 0121 616 3462 Keywords: Clinical Trials, Life Science, Drug Development, Quality Assurance, Assessor Paramount Recruitment Limited provides services as an agency and an employment business. We regularly have similar roles in this area. Please see our website for details or send your CV in to us to find out the latest opportunities.