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Details

QA Specialist


Reference:POR651453 Location: Limerick
Qualification:DegreeExperience:2-3 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: QA Specialist

A QA Specialist with GMP experience is required to join a leading global Biopharma business in Limerick. The focus of this role is toperform activities in support of dispositioning product and/or raw materials while ensuring compliance with Quality Assurance (QA) policies and procedures, cGMPs, SOPs, and Standard Requirement Documents.

The Role;

  • Represent Quality Assurance in support of complex Deviations, Change Controls, CAPAs, etc., including active participation in investigation, evaluation, and problem resolution
  • Train and/or mentor junior employees, including providing insights and education on processes and procedures;
  • Provides consultation or advice in alignment with QA policies;
  • Perform activities associated with disposition of raw materials and product (e.g. manufacturing record review, receipt, inspection, document review, shipping, etc). Activities may be on the floor or at a desk
  • Review, edit, or approve controlled documents
  • Review and approval of investigations associated with raw materials, product, laboratory,acilities, and materials.
  • Perform status labelling of raw materials and product
  • Continually evaluating processes and procedures with an eye toward continuous improvement


The Person

  • Requires BS/BA in scientific discipline or related field and minimum 2 years QA experience
  • Understanding of biologics manufacturing operations is preferred but candidates from the broader pharmaceutical industry will also be considered
  • Good organizational skills and attention to detail
  • Requires good written, verbal and interpersonal communication skills and the ability to effectively interact cross functionally.
  • Ability to handle multiple assignments and changing priorities.
  • Ability to stand for periods of time when performing tasks on the floor.
  • Ability to work a varied schedule including off shift and weekends.