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Quality Control Manager

2 weeks ago

Dublin, Dublin City, Ireland beBee Careers Full time

Job Overview

The Quality Control Manager - Sterile Drug Product will be responsible for leading the development and implementation of quality control processes for sterile drug products.

This role involves providing technical expertise and guidance to relevant site functions in accordance with c GMP regulations. Key responsibilities include developing, maintaining, and overseeing sample management lab programs for the Drug Substance and Drug Product facilities.

Your Main Responsibilities:

  • Development and maintenance of sampling and analysis plans for Biological Drug Substance and Drug Product samples.
  • Oversight of the QC VMI program to drive lean capacity and minimize expiry losses.
  • Management of inventory storage strategy for training samples and Reference Standard Critical Reagent program for QC.
  • Technical expertise in areas such as sample processing activities, Drug Substance & Drug Product Sampling, retain program management, and sample lifecycle controls.
  • Leadership and guidance to the QC Sample Management team on laboratory procedures and practices.