QP

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The Role: Commercial supply chain oversight and QP certification of contract manufactured products where the company is the named importer and batch release site within Marketing Authorisations held within the (European Economic Area) EEA. In support of Qualified Person Certification activities, maintain and develop the Quality System that supports batch certification and release operations within the company ensuring maintenance of GMP requirements for batch release and the conditions of the Manufacturers Import Authorisation (MIA).The company: Pharmaceutical company working to change patients' lives by developing medicines to treat addiction and serious mental illnesses. The medications provides play an essential role in treating opioid use disorder and addressing the opioid crisis.Responsibilities: Supply Chain and Contractor relationships and product familiarisationBatch certification and release productQuality Management SystemLicence ResponsibilitiesRequirements: At least five (5) years experience working in a Healthcare or Pharmaceutical related industry.QP status is essentialWorking knowledge of EU and FDA Medicines legislation and good practices. Knowledge of Wholesaling legislation in EU and EEA countries eg EU 2013/C 343/01, EU 2015/C 95/01Working knowledge of EU and EEA controls.Not sure yet? No CV ready? Please get in touch for more information. To find out more about Real please visit www.realstaffing.comReal 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