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Wembley

    Quality Assurance Specialist - Wembley, Greater London, United Kingdom - Medicareplus International Ltd

    Medicareplus International Ltd
    Medicareplus International Ltd Wembley, Greater London, United Kingdom

    1 week ago

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    Description


    Job SummaryQA Specialist is responsible for ensuring continued compliance of the Quality ManagementSystem of the company with the relevant Medical Device Directives, Medical Device Regulations,International Standards, and Customer Requirements and that this is maintained andimplemented accordingly.

    ResponsibilitiesProvide day-to-day support and be responsible to maintain the effectiveness of theQuality Management System, including, but not limited to, Document Control, CAPA,Vigilance, Risk Management, Internal Audit, Post-Market Surveillance, Supplier Monitoring and Assessment and Product Release activitiesContribute to strategic improvement projects to improve business processes in line with the applicable regulatory requirements and Medicareplus Regulatory StrategyPrepare and present Quality Data to analyse quality trends and support investigations,remediation and improvement initiativesAccountabilitiesMaintain current knowledge base of existing applicable and emerging regulations, standards, or guidance documentsTo support and participate in the development of effective and efficient documentedways of working for the verification of all quality related activities associated with themanufacture of outsourced raw materials and finished products.

    To collate and review batch records, certificates of analysis/conformance, sterilisationdata from subcontractors to ensure that products are made available for sale inaccordance with agreed lead-timesTo participate in the effective management of Customer Complaints, RegulatoryReporting, Non-Conformances and CAPATo prepare and analyse data for the purpose of Management ReviewTo ensure that all Change Control activities are effectively controlled, and outputs arecorrectly translated into documentationTo ensure that the Labour Standard Assurance System and the Modern-Day Slavery Actare effectively managed, and all requirements metTo participate in and support internal, supplier and external audit programmeWrite or update Standard Operating Procedures and work instructionsSupport the RA function as directedKey challengesMaintain frequent contact with external sub-contract manufacturers and suppliers To collate data from multiple sources, interpret and produce meaningful qualityreports with justified and balanced evidence and proposal for remediations as applicableTo work to tight deadlines and manage a workload which has designated lead timesTo show initiative in problem solving by identifying and recommending solutions toproblems encounteredTo maintain a personal knowledge of the current Quality Management System andRegulatory RequirementsPlease note that the duties and responsibilities within this role may change over the course of employment, which will require flexibility.



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