This is an 11-month contract with our Pharmaceutical client in Carlow.
The Quality Assurance Specialist role supports the introduction and execution of new products, materials, and drug substances into the facility. The QA Specialist (NPI / DS / Materials) will participate as a core member of the Technical Transfer Team that manages Vaccine and Biological product development and manufacture, along with day to day QA activities, including:
1. Ensuring that the process for the introduction of biologics/vaccines is in compliance with cGMP and the associated regulatory requirements.
2. Reviewing and approving documentation to support corporate compliance/regulatory expectations for manufacturing.
3. QA oversight on the receipt and release of Drug Substance to sight.
The role reports to the Associate Director of Quality who will liaise with cross-functional teams on site, in particular, Supply Chain, Technical Engineering, QPs, and Operations to ensure manufacturing, technical and regulatory requirements are met.
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