Quality Assurance Specialist

hace 1 semana


Barcelona, Barcelona, España Bespoke Recruitment Limited A tiempo completo
Job Title: Quality Assurance Specialist - Dublin

We are seeking a highly skilled Quality Assurance Specialist to join our team in Dublin. As a Quality Assurance Specialist, you will play a crucial role in ensuring the quality of our products and services.

Key Responsibilities:

  • Support the Quality Manager in maintaining compliance with Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), and internal Quality Systems.
  • Assist in the development of continuous improvement and compliance projects within the Quality Department.
  • Define and update Quality Procedures in conjunction with operating staff, ensuring compliance with GMP and GDP.
  • Prepare information for presentation at the Quality Review Board meetings.
  • Assist in the completion of internal audits of GMP/GDP systems.
  • Ensure the GMP and GDP elements of the Quality Management system (QMS) are understood by training company personnel.
  • Record, investigate, and report incidents and deviations to the Quality Manager.
  • Assist Process Owners in assessing risks and assigning counteractive measures.
  • Conduct Supplier Audits and Assessments, as required.
  • Manage and update Technical Agreements.
  • Document and manage relevant change controls.
  • Ensure adherence to the stability schedule.
  • Manage stability data for the support of expiry dates.
  • Coordinate customer and supplier complaints, including investigations, reporting, and trending.
  • Assist in the coordination and documentation of product recalls and mock recalls.
  • Support Pharmacovigilance, Medicovigilance, and Compliance activities, as required.

Requirements:

  • Bachelor's degree or higher in a related Science discipline.
  • Demonstrated ability in quality systems support.
  • Knowledge of EU quality-related pharmaceutical regulations.
  • Experience of a MIA environment.
  • Experience in dealing with 3rd-party warehouse distribution models.
  • Ideal candidate will have 3-5 years of experience in a pharmaceutical/regulated background with strong working knowledge of GMP, regulatory expectations, and familiarity with aseptic processing.


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