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Runcorn

    Quality Director - Runcorn, United Kingdom - Real

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    Permanent, Full time Healthcare
    Description
    Our client is an established pharmaceutical company looking to add a Quality Director to head up a Quality department.

    The Quality Director will promote and integrate quality into every aspect of the business ensuring GMP compliance and meeting the authority's expectation.

    The role holder will perform all duties required of a Quality Director, provide leadership to the Quality Teams, improve the QMS, provide expertise and guidance on changing regulatory landscape and input in operations that protects company reputation whilst maintaining product supply to market.

    The role holder will be named as Qualified Person on Manufacturer and Importer Authorisations.

    The Role:
    Work with and manage the Quality team to enable the efficient evaluation and release of medicinal products
    Work closely and effectively with other departments such as Regulatory Affairs, Compliance, Validation, Sales, Logistics etc to the highest quality and compliance standards and maintaining product supply to market
    Act as Qualified Person to the business
    Host regulatory inspections for the business and provide support to sister company for regulatory inspections and conduct self-inspection program
    Oversee the Pharmaceutical Management System. Implement the current GMP regulations and industry best practices, where applicable
    Support and develop the QA team
    Support/lead manufacturing deviation or testing out-of-specification / out-of-trend investigations
    Audit the contract manufacturing organisation and laboratory against EU GMP and relevant regulations and guidelineQualifications and Skills:
    Qualified Person (QP)
    Knowledge and experience in manufacturing and testing of oral dosage forms and topical products
    Experience in releasing medicinal products in a fast-paced environment
    Experience in managing a QA team
    Communication skills with internal and external customers
    Overseas audits
    To find out more about Real please visit
    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 | OC(phone number removed) England and Wales

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