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.
- 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!
Following your application for this specific role, Sigmar may contact you regarding other positions that we feel you may be suitable for. If you do not wish to be contacted about other opportunities please let us know. For further information please refer to the Privacy Statement on our website.