QA Manager, RP

Real Staffing ,
Slough, Berkshire
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Overview

QA Manager, RP I am currently working with an exciting, rapid-growth clinical supply company based in Berkshire who are looking to take on a permanent QA Manager, RP. The purpose of the role will be to ensure that compliance with MHRA guidelines concerning medicines & Home Office guidelines for Controlled Drugs. The Responsible Person (RP) is responsible for safeguarding product users against potential hazards arising from poor distribution practices and to be knowledgeable of UK and EU legislation as outlined in the Job Requirements. Key Responsibilities: To check ALL goods received are not counterfeit medicines, by looking for evidence of tampering or anything suspicious. Check product description, quantities, expiry dates, batch numbers are accurately recorded and match POs. To ensure goods that have been delivered by bona fide suppliers are to a high standard. For cold chain products ensure goods have been maintained at 2-8°C by checking temp traces and storing them in the RP database, clearly labelled Ensure that the conditions of the wholesale dealer's license are met, and the guidelines of Good Distribution Practice are complied with. Liaise with the MHRA and Home office as and when necessary. To be present for any visits by the MHRA and/or Home Office. Liaise with QP for goods arriving from outside the EU Key Requirements: To have acted as a Responsible Person To have worked with Investigational Medicincal Products (IMPs) To have knowledge of Good Distribution Practice (GDP) Knowledge of The Medicines Act 1968. Knowledge of Eudralex, The Rules Governing Medicinal Products in the European Union, Volume 4 Good Manufacturing Practice, Medicinal Products for Human and Veterinary Use. Good Understanding of the Wholesale Dealer's Licence. Knowledge of, The Human Medicines Regulations ( UK SI 2012 1916). If this QA Manager, RP role looks like it could be the next step in your career, please get in touch as soon as possible to give yourself the best chance of securing an interview To find out more about Real please visit www.realstaffing.com Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales

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