Shire Responsible Person, Quality Specialist in Istanbul, Turkey

Primary Duties

  • Responsible Person for Turkey - managing the product release process as per local legal requirements

  • Assure implementation, maintenance and advancement of a systematic and efficient quality assurance system according to applicable regulations

  • Primary contact for Turkish supervisory authorities. Own relationship/communication with the local GDP Authorities, and host inspections in Turkey

Responsibilities

  • Ensure Shire establish and retain all applicable licenses and permits required to import and distribute Shire products in Turkey

  • Participate in product release process as per local MOH requirements

  • Own relationship and manage communication with local GDP; Prepare and host GDP and CS inspections and manage the inspection response. Keep abreast of trends and changes in local Regulations, assess the impact of new Regulations on Shire Turkey and Distributors

  • as the RP: Own Quality and Technical Agreements, may lead or support Supplier and Distributor Audits, and Quality review meetings. Manage daily interaction and communication flow with external partners. Own final disposition on returned, rejected, recalled or falsified products; authorize and manage product rework and destruction with the support and approval of GMP groups such as QA and QP. Responsible for oversight of qualification of new external partners.

  • Responsible for Document management, training management and implementation of any and all required local and global Quality management systems

  • Assure the Shire Management System (QMS) in Turkey is compliant with the European and national regulations, and with Shire Global QMS, including SOPs, Change Control, CAPA, Record management, internal audit, mock recall, suspect counterfeit handling and management review systems.

  • Support the introduction of Investigational Medicinal Products in Turkey

  • Ensure QA oversight of Shire Distributor partners in Turkey including managing QA audit, QTAs, product launches, and qualification of new external partners.

  • Provide Quality support to the local operation, for both the existing business and the new product launches. Develop close relationships with other internal functions e.g. Business Units, Regulatory Affairs, Pharmacovigilance, Supply Chain, Global Quality

  • Is accountable for all quality KPIs for the Turkey country cluster, and other countries within EMEA, as required.

  • As an active member of Shire Global QA Community, contribute to develop and strengthen Shire global quality management systems, and provide flexible support to Shire business both at the country cluster level and global level.

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Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.

Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.