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QA Specialist, Small Molecule

Job ID R0042470 Date posted Aug. 19, 2021 Location Dublin, Ireland

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Job Description


The QA Specialist is responsible for the coordination of validation activities on site ensuring compliance with current regulatory requirements. The QA Specialist will have specific and varying duties as assigned by the Head of Quality Assurance. The role will primarily liaise and support the Small Molecule Manufacturing facilities. 


  • Provide expertise in the area of validation at Takeda Ireland Limited, Grange Castle (TILGC), ensuring compliance with current industry regulations, guidelines and trends.
  • Reviews master and completed qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria.  Including but not limited to:
    • Laboratory equipment validation.
    • Process validation.
    • Cleaning validation.
    • Qualification of premises, equipment and utilities.
    • Computer system qualification.
  • Prepare and maintain policies and SOPs associated with validation.
  • Ensure that all TILGC change controls are assessed for impact on validation.
  • Review and Approval of TILGC validation master plans.
  • Review of deviations and non-conformances associated with validation activities.
  • Execute validation protocols when required, including preparation of, and review of, deviations associated with validation activities.
  • Review and provide input into the TILGC periodic review and revalidation programme.
  • Participate in cross-functional project teams as the validation representative.
  • Support QA Operational activities as required.
  • Participate in TILGC Continuous Improvement programmes.
  • Participate in other projects as directed by the Head of Quality Assurance
  • Flexibility is important and responsibilities may change or other duties may arise for this position.


  • 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 TIL 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.


  • Minimum of a BSc Degree (life science).


  • A minimum of 5 years working within quality in the pharmaceutical industry.
  • Validation experience preferable.


  • Excellent verbal and written communication skills
  • Self-motivated, flexible, organized and a good team player with the ability to prioritize own work based on departmental and site requirements
  • Ability to work on own initiative.


Grange Castle, Ireland

Worker Type


Worker Sub-Type

Fixed Term (Fixed Term)

Time Type

Full time