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Aseptic Lead

  1. Ireland, Dublin
Dublin
  1. Contract
Competitive
  1. Compliance / Quality Assurance
37100
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Aseptic Lead - Ireland, Dublin - 12 Months Contract

Our client, a globally recognised pioneer in Biotechnology, are recruiting for the position of Aseptic Lead. A leader in the industry, our client focuses on areas of high unmet medical need and leverages its expertise to stride for solutions. This is your chance to join them on their global mission to better the lives of those effected by disease and illness.

Responsibilities include:
  • Perform as a knowledgeable subject matter expert (SME) for the filling aseptic operations.
  • Provide cross-functional development and technical expertise to the filling operations team in the aseptic Filling department in the Albumin plant.
  • Develop supervisors to become subject matter experts in aseptic techniques and behaviours and continue to provide technical support.
  • Provide input and expertise on sterile standards, guidelines in Annex 1 2023, Annex 15, and EU GMP Guide.
Requirements:
  • Strong Knowledge of Sterile Manufacturing Processes
  • Experience with regulatory compliance in cGMP manufacturing and in-depth knowledge of EudraLex Volume 4, Annex 1 Manufacture of Sterile Medicinal Products and Eu GMP guide.
  • Knowledge of Filling and Aseptic Practices, sterilisation, GMP regulations and Quality operations
  • Strong knowledge of Environmental, Monitoring, personnel monitoring and contamination control
If this role is of interest, please apply now!
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