Senior Quality Assurance Specialist

vor 3 Wochen

Frankfurt am Main, Hessen, Deutschland Grifols Vollzeit

About Grifols

Grifols is a global healthcare company that has been working to improve the health and well-being of people around the world since 1909. We are leaders in plasma-derived medicines and transfusion medicine, and we develop, produce, and market innovative medicines, solutions, and services in over 110 countries and regions.

Job Summary

We are seeking a Quality Assurance Manager / Deputy Technical Director to efficiently and effectively ensure all Quality activities in compliance with national and international GXP requirements and local laws as well as Grifols internal policies for all products distributed by Grifols Deutschland GmbH.

Key Responsibilities

  • Serve as the responsible person according to §52a AMG and the agreed internal responsibility matrix (as notified to the supervisory authority).
  • Be the back up to the Technical Director in all aspects of the QA-responsibilities.
  • Provide Quality Assurance review for storage and distribution of Biopharma and Diagnostics products in Germany.
  • Establish and ensure adherence to Grifols Quality-Systems and Policies as well as to European and local directives and legislation, including (but not limited to) maintenance of QA Systems SOPs, examining and supervising GxP compliance of storage and distribution of Grifols products, conducting self-inspections and internal audits as well as external audits of distributors, wholesalers and other third parties as assigned, etc.
  • Manage relevant QA systems, e. g. product technical complaints, deviations, documentation, change control, corrective actions, trainings and audits according to responsibility matrix and in coordination with the QA team.
  • Manage applications for OCABR as well as national release to the German OMCL (PEI).
  • Ensure establishment of Quality Management Business Review programs and annual business reports in cooperation with Technical Director and QA Team.
  • Support authority inspections.
  • Ensure QA relationship and agreements with contracted third parties.
  • Issue or review and approve reports for deviations, CAPA, change control and other relevant quality documents.
  • Ensure TD/QA onboarding for new hires.
  • Serve as the Key User for SAP QA Processes.

Requirements

  • You have a University Degree in Life Sciences (Biology, Pharmacy, Chemistry or similar). A Master's Degree is also required.
  • You have at least 3 years of relevant experience in Quality Assurance, Quality Control and/or Quality Management
  • You have knowledge of Document Management System and Project Management (desirable)
  • You possess good communication and organization skills.
  • You are a structured, self-motivated and results-oriented person, and team player, able to collaborate with cross functional teams to achieve the objectives.
  • You speak fluent German and English.

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