Quality Assurance Specialist

5 days ago

Dublin, Dublin City, Ireland beBeeAssurance Full time €90,000 - €120,000
Job Summary

We are seeking a highly skilled Quality Assurance Specialist to join our global supply quality team. As part of this role, you will be responsible for ensuring the highest standards of quality in our contract manufacturers.

Main Responsibilities:
  • You will act as disposition manager, ensuring batch disposition activities are completed in accordance with industry standards and regulations.
  • You will manage and drive quality records to closure, including deviation records and investigation reports.
  • You will initiate quality records for supplier-related changes.
  • You will collaborate with the complaints team to request assessments, review complaint reports, and ensure comments are addressed.
  • You will provide data to support quality management processes.
  • You will prepare, review, and approve SOPs and other GMP/GDP documentation to ensure compliance with corporate and regulatory requirements.
  • You will participate in operational and quality improvement initiatives, programs, and projects.
Key Requirements:
  • You must have a minimum of 4 years of experience working in a cGMP manufacturing environment with a strong understanding of regulatory requirements and expectations.
  • You must have the ability to positively impact others and affect their behaviors by connecting with and inspiring them.
  • Prior experience in batch release activities is highly desirable.
  • You should have a good working knowledge of SAP.
  • Experience in investigations, project management, and trending and analysis is a plus.
  • Relevant experience in supplier management, raw materials, packaging components, and/or device manufacturing is beneficial.
  • You should have an understanding of applicable manufacturing/testing processes.
  • You should have proven experience in designing and/or improving processes at a conceptual level.
  • You should be able to partner effectively with internal and external stakeholders across teams.
  • You should have an understanding of industry requirements/expectations of a robust quality management system and documentation.

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