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Qualified Person

Job description

Job Responsibilities

  • The QP will be responsible for 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)
  • QA oversight of routine manufacturing, testing and relating activities to ensure on-going cGMP compliance.
  • 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.

The next QP should have a degree in a scientific discipline and must be QP Qualified. You should have a minimum of 3 years’ experience in the pharmaceutical industry in a Quality role with experience in a a sterile manufacturing enviornment. 

 

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