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QA Specialist - MES

Reference:POR/A005604so Location: Limerick
Qualification:DegreeExperience:2-3 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: QA Specialist

AQuality Assurance Specialist MES is required to join a leading global Biotechnology organisation. This is a newly created role where you will be the lead QA representative for the recently implemented MES. You will be responsible for the review and approval of QA procedures associated with the Manufacturing Execution System.

The Role

  • Support the dispositioning of product and/or raw materials while ensuring compliance with Quality Assurance (QA) policies and procedures, cGMPs, SOPs, and Standard Requirement Documents.
  • Work directly with the MES and Operations teams in the design and development of electronic Master Batch Records and Equipment Specifications for site processes/products.
  • Perform activities associated with the approval of design specifications, electronic Master Batch Records and MBR Testing.
  • Perform the QA review and approval of the executed Electronic Batch Records to support product disposition.
  • 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;
  • Review and approval of investigations associated with raw materials, product, laboratory, facilities, and materials.
  • Perform status labelling of raw materials and product

The Person

  • Requires BS/BA in scientific discipline or related field and minimum 2-year relevant experience.
  • MS/MA in scientific discipline or related field
  • Experience with Manufacturing MES Systems
  • Understanding of biologics manufacturing operations is preferred
  • Ability to work a varied schedule including off shift and weekends.

If you would like further Information you can contact the recruiter directly:

Paula O'Reilly | Tel: +353 (0) 1 507 9265