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    Regulatory Affairs and Quality Manager - Northampton, Northamptonshire, United Kingdom - Real Staffing

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    Description

    Our client is an international specialty pharmaceutical company which focuses on the development, manufacturing and marketing of innovative prescription, generics and OTC pharmaceutical products.

    Experiencing rapid growth with a diverse product portfolio that spans branded and generic products sold in 30 countries worldwide.

    They are looking to add a Quality Compliance Manager to the team.
    Oversee and help to maintain various Quality Assurance processes ensuring compliant receipt and approval of incoming products from third party contract manufacturers
    The Quality Compliance Manager will ensure delivery and batch paperwork are provided in a timely manner and good order
    Helping to prepare and approve delivery paperwork to allow final release
    Ensure all SOP's, Technical Agreement's and Quality Documentation are kept up to date and are followed
    Liaise with Regulatory Affairs and respective manufacturing sites to ensure product license variations are managed in a timely manner to ensure ongoing compliance
    Help support ongoing compliance with Medical Device and Food Supplement requirements
    Working with the Quality Team and other functional departments
    The Quality Compliance Manager will be responsible for supplier Management with outsourced partners, third party contract manufacturers as required
    Regulatory records of all applications submitted to the MHRA and other agencies, artwork co-ordination, complaints for third party contract manufactured products
    Assist in the management, review and filing of the annual product quality reviews, technical agreements and compliance when required, including deviations, change control and complaints
    Knowledge and experience with Medical Device
    Salary + Bonus and Benefits Package
    Hybrid Working (3 days on-site)
    Career development in a growing organisation
    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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