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Qualified Person CMO

Job ID R0041779 Date posted Aug. 19, 2021 Location Dublin, Ireland

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Job Description


The Qualified Person is a key member of the Quality Assurance team associated with QP Certification of drug product at Takeda Ireland Limited Grange Castle (TILGC).   

In particular, the Qualified Person will assume the role of Qualified Person for the release of drug product in accordance with EU Directive 2001/83/EC.

In accordance with business needs, the Qualified Person may assume responsibilities in any work area of the TILGC Quality Department.

As with all site personnel, the Qualified Person is responsible for promoting a culture of Regulatory Compliance and Continuous Improvement within the Quality Department and across the TILGC site.


The responsibilities of the Qualified Person include the following:

  • Quality oversight of contract manufacturers, testing and for leading, monitoring and supporting the quality performance of quality systems according to GMP standards which consists of, but not limited to, change controls, deviations, CAPAs, complaints, documentation and material supplier management.
  • Ensuring effective participation as the Quality Assurance representative in Material Review Boards, CMO Quality Reviews and Supply planning
  • Management of batch disposition of drug product; site CMO Qualified Person
  • Management of review of CMO Batch Manufacturing Records (BMRs).
  • Generation of Key Performance Indicators within the Quality Assurance area to align with company and global quality objectives.
  • Participation in the Global Audit programme of CMOs.
  • 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.
  • Communication and liaison with other Takeda sites on Quality issues (as required), providing guidance and support to others.

Supervisory duties for Quality Assurance personnel may be part of the role


  • Participate fully in any cross functional training initiatives.
  • Drive and promote the corporate values of Takeda-ism within the workplace.
  • Actively foster, in cooperation with other staff, an ethos and culture of safety awareness where safety is accepted as an integral part of the overall business. Ensure that Accident Reports / Near Miss Forms are completed in a timely manner after an event.
  • Ensure timely completion of all SOP, reading, training and assessment.
  • Other duties as required and directed by the relevant Manager or other Officer appointed by the Board of Directors.


  • Primary Degree in a scientific discipline
  • Must meet the educational requirements of a Qualified Person as per EU Directive 2001/83/EC


  • Minimum of 5 years’ experience in the pharmaceutical industry in a Quality role.
  • Experience of oral solid dosage manufacture.


  • Excellent knowledge of Good Manufacturing Practice as described in current FDA & EMEA regulations for oral solid dosage pharmaceutical manufacture.
  • High level of initiative.
  • Excellent verbal and written communication skills.
  • Strong project management and organisational skills.
  • Ability to adapt to changing priorities.
  • Qualified Person status is essential


Grange Castle, Ireland

Worker Type


Worker Sub-Type


Time Type

Full time