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Quality Assurance Associate, Cell Therapy

Dublin, Ireland

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Quality Assurance Associate, Cell Therapy

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Job ID R0036318 Date posted 04/29/2021 Location Dublin, Ireland

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Job Description

JOB PURPOSE:

The Quality Assurance Associate is responsible for the coordination of quality activities within the Quality Assurance group and for duties as assigned by the Quality Assurance Executive for the new the P3 Cell therapy manufacturing facility in Takeda Ireland Ltd, Grange Castle.Some key tasks and responsibilities are outlined below.

RESPONSIBILITIES:

  • Coordinate and execution of batch record review
  • Coordinate and execution of area clearance record review
  • Assisting in, and facilitating, investigations as part of the site Deviation Management System, ensuring effective root cause analysis and assigning of appropriate CAPAs.
  • Support activities relating to the Quality Management System (QMS), which include, but not limited to; CAPAs, change control, material and service supplier management.
  • Assist and co-ordinate the preparation of reports in relation to Annual Product Reviews for products manufactured on site.
  • Participate in the on-site GMP Inspection schedule
  • Participate in the internal audit schedule.
  • Support the Environmental monitoring programme
  • Develop SOP & other GMP Controlled Documents.
  • Review of master records.
  • Support activities relating to customer complaints, product returns and product recall
  • Support the onsite audit team during external cGMP audits, e.g. from Regulatory Authorities and Global Quality.
  • To actively support the development/implementation of continuous improvement activities.
  • Participate in other projects as directed by the Quality Assurance Executive.
  • Actively support major projects, quality initiatives and continuous improvement programmes within the Quality department and in other functional areas.
  • Support and review process simulations (Media Fill).

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 timely completion of all SOP, reading, training and assessment.
  • Other duties as required and directed by the relevant Manager

EDUCATIONAL REQUIREMENTS:

  • Bachelor's degree in chemistry, biology or a related scientific discipline.

RELEVANT EXPERIENCE:

  • Experience in quality in the pharmaceutical industry.
  • Experience working in cell culture/ finished product pharmaceuticals/ biologics, including biochemistry, microbiology, quality assurance, quality control, development, and/or manufacturing areas.
  • Understanding of quality and cGMP's.

SKILLS/COMPETENCIES:

  • Excellent verbal and written communication skills.
  • Be self-motivated, flexible, organised and a good team player with the ability to prioritise own work based on departmental and site requirements.
  • Work directly with other key departments to ensure compliance and productive working relationships.

Locations

Grange Castle, Ireland

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job ID R0036318
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