QA Specialist -Packaging

Job Overview

QA Specialist -Packaging - Dublin-Flexible work pattern
Excellent opportunity for a QA Specialist to join a leading biopharma company in Dublin. The ideal candidate will have a minimum of 3 years' experience in a QA function (Packaging/Complaints ideal) within a highly regulated environment.
This is a superb opportunity to work in a QA environment for a global biopharma company that serve patients with life-improving treatments ,working here will be a fantastic addition to your CV. Your work will truly make a difference to people's lives and you will work alongside cutting-edge technology and a supportive and friendly team.


Responsibilities of QA Specialist Job:

  • Responsible for the Quality support functions associated with the packaging of products for clinical and commercial batches
  • Performs batch record review, product release, and disposition
  • Reviews production logbooks for GMP compliance as each operation is completed and revises SOPs as needed
  • Assists in the execution of efficiency improvement projects
  • Ensures that products are manufactured, packaged, tested and released according to applicable FDA guidelines, regulations and internal SOPs
  • Participates in QA programs, procedures and controls to ensure that products conform to established standards and guidelines
  • Ensures gathering of data, investigations and deviations are timely and compliant
  • Follows all Good Documentation Practices and cGMPs to ensure compliance to applicable FDA guidelines and MHRA guidelines
  • Respond and interact with internal and external clients in a professional and timely manner
  • Other duties as assigned


Requirements of QA Specialist Packaging Job:

  • Degree qualified in Engineering/Science discipline
  • 5 years+ experience in pharma,med device or biotech industry
  • Experience in managing Root Cause Analysis / Non Conformance /Deviation investigations/complaints
  • Knowledge and experience of regulatory requirements/inspections

Flexible work pattern
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