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Details

QA Specialist - External Manufacturing


Reference:PORA005750 Location: Limerick
Qualification:DegreeExperience:2-3 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: QA Specialist, EHS Specialist

A QA Specialist/ Senior Specialist - External Manufacturing is required to join a leading biopharmaceutical organisation in Limerick. The focus of the role is to perform activities in support of dispositioning product while ensuring compliance with Quality Assurance (QA) policies and procedures, cGMPs, SOPs, and Standard Requirement Documents.

Responsibilities

  • Represent Quality Assurance both internally and Externally with Partners and Contract Manufacturers 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; and develop an understanding of external partner and manufacturers site procedures.
  • Perform activities associated with reading product records for disposition (e.g. manufacturing record review, receipt, inspection, document review, shipping, etc.). Activities may be on site at a partner or contract manufacturer or at a desk
  • Review and approval of investigations associated with raw materials, product, laboratory, facilities, and materials.

The Person

  • Requires BS/BA in scientific discipline or related field
  • A minimum 2 years’ experience in a quality assurance role.
  • Experience of aseptic filling is essential
  • Good organizational skills and attention to detail
  • Requires good written, verbal and interpersonal communication skills and the ability to effectively interact cross functionally. and cross-organizationally.
  • Ability to handle multiple assignments and changing priorities.
  • Ability to work a varied schedule including off shift and weekends.
  • Ability to travel up to 25% of time





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



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