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Quality Assurance Specialist-Sterile Operations

  • Salary: Negotiable
  • Job type: Permanent
  • Location: Munster
  • Sector: Science
  • Date posted: 17/01/2019
  • Job reference: BBBH96309

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Quality Assurance Specialist-Sterile Operations

My client, a leading pharmaceutical organisation based in the south east is currently seeking a QA Specialist to join their team. In this role you will be reporting directly to the Quality Assurance Team Leader and will play an integral role within the Sterile Operations.

Key responsibilities

  • Acts as Quality Point person for systems / processes providing guidance / feedback on quality issues related to Sterile Manufacturing activities
  • Working as part of the Quality Assurance team on site ensuring products are manufactured, stored and packaged in accordance with cGMP
  • Perform timely review of documentation / investigations / reports highlighting and assisting in the resolution of concerns commensurate with the risk
  • Work with relevant departments to ensure timely closure of quality actions / findings
  • Actively contribute to continuous improvement initiatives

Essential requirements:

  • Minimum 5 years' experience working in a Sterile manufacturing environment
  • Provide ability to provide quality expertise & support to the QA team and site
  • Proven ability to support the delivery of tasks in a highly regulated manufacturing environment
  • Effective technical knowledge of sterile manufacturing processes
  • Effective technical knowledge of sterile manufacturing processes
  • Operational experience of quality systems in a dynamic manufacturing environment
  • Knowledge of requirements for cGMP, US and EU regulatory requirements
  • Full understanding of relevant quality and compliance regulations

For more information on this and other opportunities please contact Kathryn on 016455250 or visit our website

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