QA specialist

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Key Role Activities

Prepare, update and approve procedures in accordance with GMP/GDP and company requirementsManage all documents in accordance with records managementAssist in the implementation and update of internal or external standardsIdentify and Log Quality Issues, perform impact assessments and lead investigationsCollaborate effectively with various internal and external partnersEnsure appropriate management of non-conformances related to GMP and GDP, internal and external change controls and CAPAs.Support the Quality Manager with monitoring and oversight of outsourced activities.Perform allocated internal audits as requiredSupport and participate in local initiatives or projects to increase compliance and reduce costs/non-conformance.Provide the necessary input to the Quality Manager for the bi-annual management review of the Legal Entities.Support the process for intake of medicinal queries and complaints, ensuring timely case processing.Maintains the Wholesale Distribution Authorisation, ensuring compliance with the general conditions detailed, in line with European and local regulations.To ensure compliance with the requirements of Good Distribution Practice (EU GDP).To ensure that all aspects of the quality system are implemented and maintained.Ensure that the quality, safety and traceability of medicinal products are maintained within the supply chain.To ensure appropriate competence and experience as well as knowledge of and training in GDP.If you are interested in this role and would like to learn more, please respond to this advert, and a member of the team will be in touch.*Please note, in order to be eligible for this role you must hold an EU passport, or a stamp4 visa*Please click here to find out more about our Key Information Documents. Please note that the documents provided contain generic information. If we are successful in finding you an assignment, you will receive a Key Information Document which will be specific to the vendor set-up you have chosen and your placement.To find out more about Real please visit www.realstaffing.comReal Staffing, a trading division of SThree Partnership LLP is acting as an Employment Business in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales