Quality Assurance Specialist

Employer: Novartis Pharma Services Romania
Domain:
  • Chemistry - Petrochemistry
  • Quality Control
  • Pharmacy - Health
  • Job type: full-time
    Job level: 1 - 5 years of experience
    Location:
  • BUCHAREST
  • Updated at: 20.02.2019
    Short company description

    Novartis este unul dintre liderii din industria medicala la nivel global si un angajator important, cu peste 120.000 de angajati. Compania are sediul central in Basel, Elvetia si ofera solutii inovatoare pentru nevoile, in continua crestere, ale pacientilor din intreaga lume. Produsele companiei sunt disponibile in peste 180 de tari la nivel mondial.

    Requirements

    • Degree in Pharmacy or related fields (such as Medicine, Biochemistry, Chemical engineering);
    • Fluency in English, both written and spoken;
    • Minimum 1 year of experience in the pharmaceutical industry in quality assurance/ regulatory affairs/ pharmacovigilance/ clinical studies area;
    • Qualified person certificate – would be a plus;
    • Solid knowledge of legislation and the quality assurance management systems;
    • Solid knowledge of the GxP area;
    • Experience in managing complaints and deviations;
    • Experience in training delivery.

    Responsibilities

    • Managing complaints, deviations, CAPAs, support recalls, destructions, and archiving according to the Novartis Quality Manual and local/global written procedures;
    • Supporting GxP Quality Manual implementation, included but not limited to tracking of QA Manual implementation, writing/reviewing of LWPs/LPs as assigned by Country QA Head ;
    • Maintaining current knowledge of relevant regulatory and legislative requirements and trends;
    • Ensuring, together with QA Head, previous preparation and facilitate the conduct and coordinate the follow-up of GxP related Health Authority inspections and internal audits at CO level, vendor level and investigator sites;
    • Supporting assessment, qualification and management of local third parties;
    • Supporting Country QA Head in all GxP related activities as needed during absence of GMP/Dev Manager;
    • Being responsible for implementing specific QA project tasks and reporting the related actions to QA Head;
    • Conducting proactive in-process quality and compliance review through monitoring of adequate Key Quality Indicators (KQIs) and assuring that gaps are addressed appropriately in order to mitigate risk;
    • Providing training to associates within the company, regarding local/ global quality assurance procedure.