Ciara Rafferty

Ciara Rafferty

Senior Executive Quality Assurance

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  • Timeline

  • About me

    Head of Commercial Quality Supply Chain Governance

  • Education

    • Trinity College, Dublin

      2002 - 2006
      Bachelor's degree Medicinal and Pharmaceutical Chemistry
    • Dublin Institute of Technology

      2006 - 2007
      Master's degree Pharmaceutical Quality Assurance & Biotechnology
  • Experience

    • GSK

      Oct 2007 - Dec 2012
      Senior Executive Quality Assurance

      Senior Quality Executive: Nov2011- Dec 2012Responsible for operational quality activities for GSK Ireland, including management of the quality management system ensuring adequate document control and deputy Responsible Person on Wholesale license to ensure compliance with the general conditions of the product authorisation and ensuring compliance with the requirements of GDP.Quality & Pharmacovigilance Advisor: Mar 2010- Nov 2011Pharmacovigilance & Quality Officer: Oct 2007- Mar 2010Compliance Officer: Jun 2007- Oct 2007 Show less

    • Atlantis Healthcare

      Feb 2013 - Aug 2013
      Quality Assurance Specialist

      Management of the Quality Management System (QMS) for Atlantis Healthcare ensuring implementation, supervision and administration of all quality procedures and SOPs, both local and corporate in compliance with Global Processes. Including procedures on document management, adverse event report and training. Perform duties in a compliant manner and behave in accordance with the Quality Management System requirement.

    • Novartis

      Sept 2013 - Mar 2014
      DS&E Associate

      Responsible for collection, processing, documentation, reporting and follow-up of all adverse events (AE) reports for all Novartis products from clinical trials, post-marketing studies (PMS), Spon¬taneous Reports (SR), registries, commercial programs, etc.

    • Cadifern Ply Ltd, Australia

      Mar 2014 - Oct 2014
      QA, WHS & Environmental Consultant

      Responsible for maintaining a safe work environment through encouraging a safe workplace culture and raising awareness to reduce the number of incidents and injuries. Achieve and ensure compliance with ISO 9001, 14001 & 8001.

    • Shire

      Mar 2015 - Apr 2018

      Cluster lead for UK & Ireland with responsibility for Distribution and Supply Chain Quality.Providing QA leadership and technical support to external suppliers in order to ensure Shire’s commercial products are distributed in compliance of GDP. Oversee quality-related licences and functions for the local operation including pharmaceuticals, biologics, controlled drug activities, medical device, and plasma derived products.

      • Associate Director, UK & Ireland Quality Lead

        Sept 2016 - Apr 2018
      • Senior QA Specialist/ Responsible Person

        Mar 2015 - Sept 2016
    • Shire

      Jun 2018 - Apr 2019
      Head of EMEA Distribution &Supply Chain Quality
    • Takeda

      Apr 2019 - now

      Responsible for ensuring the compliant operations of Takeda trading entities in accordance with approved cGxP licenses, robust Quality Management System and Governance.

      • Head of Commercial Quality Supply Chain Governance

        Apr 2025 - now
      • Head of Trading Entity Compliance

        Apr 2019 - Apr 2025
  • Licenses & Certifications

    • First Aid

    • Leading and Managing Globally

      Yale School of Management