Quality Assurance Specialist

7 days ago

Sligo, Sligo, Ireland beBeeSupplier Full time €60,000 - €90,000
Job Description:

As a key member of our team, you will play a critical role in ensuring the quality and compliance of our suppliers. Your primary responsibility will be to act as a global quality assurance (QA) subject matter expert for supplier oversight, specifically in areas such as Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), Good Clinical Practice (GCP), and Good Distribution Practice (GDP).

You will lead and improve our supplier qualification program by assessing risks, conducting audits, and monitoring supplier performance. Additionally, you will conduct audits, issue reports, track corrective action plans (CAPAs), and verify their effectiveness.

Another crucial aspect of this role is reviewing and approving supplier documentation, including agreements, responses, changes, and deviations. You will also assess supplier quality systems against global regulatory requirements, such as those set by the European Medicines Agency (EMA), the Organisation for Economic Co-operation and Development (OECD), and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).

Furthermore, you will advise on procurement strategies to ensure GxP compliance in supplier selection and support teams across various functions, including research and development, quality control, regulatory affairs, and procurement, in supplier investigations.

Lastly, you will deliver internal training on supplier qualification, enabling others to understand the importance of this process.

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