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Qualified Person - QP

Job description

The Qualified Person will assume the role of Qualified Person for the release of Cell Therapy products in accordance with EU Directive 2001/83/EC within a new state of the art facility.

Job Responsibilities;

  • Management of batch disposition and material status control activities associated with Cell Therapy Products acting as a Qualified Person.
  • Management of review of Batch Manufacturing Records (BMRs).
  • Assisting in, and facilitating, investigations as part of the site Deviation Management System, ensuring effective root cause analysis and assigning of appropriate CAPAs.
  • The Qualified Person will be responsible for management of the Change Control process associated with Cell Therapy manufacture and testing, ensuring controlled implementation of all GMP changes.
  • The Qualified Person will provide a QA oversight of routine manufacturing, testing and relating activities to ensure on-going cGMP compliance.
  • Ensuring effective participation of the Quality Assurance team in production and other site meetings.
  • Implementation of Key Performance Indicators within the Quality Assurance area to align with company and global quality objectives.
  • Participation in the site Internal Audit programme.
  • Participation in the preparation of, and hosting, external cGMP audits, e.g. from Regulatory Authorities and Global Quality.
  • Participation in the preparation of documentation for regulatory submission and participation in regulatory affairs discussions.
  • Taking a leadership role in promoting a culture of Compliance, Right First Time and Continuous Improvement.
  • Implementing efficiency improvements in Quality Dept on a continuous basis and participating in site projects and initiatives.

 

The next Qualified Person must have a primary Degree in a scientific discipline and must meet the educational requirements of a Qualified Person as per EU Directive 2001/83/EC. You should have a minimum of 4 years’ experience in the pharmaceutical industry in a Quality role with experience of sterile manufacture is essential.

If you’re looking to join a first of its kind facility in Ireland and work within a state of the art facility get in touch now!

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