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Qualified Person (QP) Part Time

Job description

PART TIME QP

JOB RESPONSIBILITIES:

 

The responsibilities of the Qualified Person (Biologics) include the following:

 

  • Management of batch disposition and material status control activities associated with Advanced Therapeutic Medicinal Product 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.

  • Management of the Change Control process associated with ATMP manufacture and testing, ensuring controlled implementation of all GMP changes.

  • QA oversight of routine manufacturing, testing and relating activities to ensure on-going cGMP compliance.

  • Participation in the site Internal Audit programme.

  • Participation in the preparation of, and hosting, external cGMP audits

  • 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.

  • Acting as a designee to the QA Manager as required.

     

     

    EDUCATIONAL REQUIREMENTS FOR THE JOB: 

  • Primary Degree in a scientific discipline

  • Must meet the educational requirements of a Qualified Person as per EU Directive 2001/83/EC.

     

    RELEVANT EXPERIENCE REQUIREMENTS FOR THE JOB:

  • Minimum of 5 years’ experience in the pharmaceutical industry in a Quality role.

  • Experience of sterile manufacture is essential.

  • Experience of biologics manufacture is desirable. 

Please review the requirements for this role and apply to Clara Henry on chenry@sigmar.ie or phone 01 4744676 for more detail.