QC Analyst 24/7 Shift
Takeda Pharmaceutical Company Limited.
Dublin, Leinster, Ireland
24d ago

By clicking the Apply button, I understand that my employment application process with Takeda will commence and that I agree with Takeda’s JOB PURPOSE :

  • The QC Analyst has an important role to play the TIL GC Quality Control laboratory and the routine operation of the QC laboratory.
  • The QC Analyst will have specific and varying duties and some key tasks and responsibilities are outlined below. As TIL GC is a 24 / 7 operation flexibility is important and responsibilities may change or other duties may arise.

    RESPONSIBILITIES : Quality Systems :

    Quality Systems :

  • Contribute effectively to the design and implementation of quality systems in the QC laboratory to meet the requirements of ICHQ7.
  • Work with other QC personnel in the preparation and review of the required documentation in the QC laboratory, including Standard Operating Procedures, Analytical Procedures, Analytical Worksheets and Material Specifications.
  • Participate, as directed, in the following activities in the QC laboratory :
  • Equipment Calibration
  • Equipment Maintenance
  • Purchasing
  • Laboratory Auditing
  • LIMS data management and maintenance
  • Analytical Testing :

  • Provide expertise in a variety of analytical test procedures.
  • Carry out sampling and analytical testing of raw materials, packaging materials, intermediates and finished API product according to approved TIL GC procedures and plant schedules.
  • Ensure that all testing information is recorded accurately and completely according to cGMP procedures.
  • Ensure that any deviations or out of specification (OOS) results are reported immediately to the QC Senior Analyst / QC Executive so that corrective action may be taken.
  • Provide assistance and guidance in deviation investigations, OOS investigations, change proposals and batch disposition.
  • Carry out status labelling of materials as required.
  • Provide samples to contract testing laboratories and liaise with these laboratories as required.
  • Validation :

  • Carry out method transfer and method validation work as required, to meet project deadlines.
  • Review equipment qualification documentation for QC Laboratory equipment.
  • Participate in the cleaning validation programme at the TIL GC facility.
  • Participate in the stability programme at TIL GC facility.
  • Good Laboratory Practices :

  • Ensure that Good Laboratory Practices are followed at all times.
  • Ensure that Analytical Method Worksheets are followed at all times.
  • Ask, if in doubt, about any particular practice or unusual finding.
  • As a member of the quality function, work with other departments to promote a culture of compliance to Good Manufacturing Practice within the plant.
  • Ensure that the Laboratory remains in an audit ready status at all times.
  • GENERAL RESPONSIBILITIES :

  • 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 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.EDUCATIONAL REQUIREMENTS :
  • Minimum of a BSc Degree (life science)
  • RELEVANT EXPERIENCE :

  • A minimum of 3 years’ work experience in a regulated GMP / GLP environment.
  • Practical experience with HPLC and GC systems.
  • Experience with writing and reviewing SOP’s / validation protocols.
  • Experience with Method transfer / validation, desirable but not essential.
  • Experience working in an API facility, desirable but not essential.
  • SKILLS / COMPETENCIES :

  • Good time management.
  • Experienced in technical writing.
  • Experience in analytical data review.
  • Ability to work on own initiative in an unsupervised manner.
  • Excellent teamwork stills.
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