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    Quality and Regulatory Officer - London, United Kingdom - ACHIEVA Group Limited

    ACHIEVA Group Limited
    ACHIEVA Group Limited London, United Kingdom

    4 days ago

    Default job background
    Description
    Senior Quality Assurance Officer
    Hybrid – 2/3-day office home.
    Mon – Fri
    To conduct, coordinate and support quality aspects of the business operation, ensuring quality compliance throughout the business with focus on WDA, MIA and GMP and GDP activities

    Degree level in a Life Science subject or equivalent in relevant experience ,BSc Pharmaceutical Studies beneficial.
    Over 3-5 years' experience within the pharmaceutical and medical devices industry.
    Proven Quality Assurance experience in the pharmaceutical, biotechnology, or CMO industry, with a solid foundation in QA principles.
    Strong analytical skills and keen attention to detail to identify and address potential quality issues.

    Proficient writing skills, using appropriate software tools to develop and edit documents, procedures, and reports, contributing to comprehensive documentation and compliance.

    Understand the role of the MHRA (and other competent authorities) in the licensing of medicines, including the risk-based inspection process, the role of the enforcement group, the Inspection Action Group (IAG) and resulting actions that can be taken due to non-compliance.

    Knowledge of Quality Management system within a pharmaceutical background.

    Ideally someone who has worked in a virtual pharma company previously and has rich experience, to work with contract organisations and manufacturers, and familiar with activities such as written, review and creation of technical quality agreements, and vendor performance review etc.

    High proficiency in office based/or similar programmes (i

    e:
    Microsoft Word, Excel, Power point, Outlook & Teams).
    Effective online communication, as well as face-to-face.
    Effective time management.
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