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QA Specialist

  1. Ireland, Dublin
Dublin
  1. Contract
Competitive
  1. Compliance / Quality Assurance
37114
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QA Specialist - Ireland, Dublin - 12 Months Contract

One of the top 10 best companies to work in Ireland is looking for QA Specialist for their large-scale new facility in Dublin. Is this you?

An exciting project there is lots of opportunity to learn new technology and develop current skills within a fast paced €1 billion project. This fantastic client offers the opportunity to work within a large-scale environment with cutting edge technology.

Responsibilities include: 
  • Compilation and review of batch release dossiers for Qualified Person certification of IMP to clinical trials.
  • Updates and maintains the site Manufacturing and Importation Authorisation (MIA) in accordance with regulatory requirements and maintains the Site Master File.
  • Generates and maintains Product Specification Files (PSF) for IMP.
  • Provides QA support and oversight of packaging and labelling operations for IMP.
  • Support the generation and ongoing maintenance of Quality Agreements.
  • Provides Quality Assurance support in the Use Date Extension process.
  • Provides Quality Assurance oversight and support (GMP/GDP guidance and training) for CSO Logistics (EMEA and Asia)
  • Supports in a timely manner, investigations of non-conformances and quality incidents as QA.
  • Generate and complete QA review of supplier/customer qualification documentation
Key requirements include:
  • A degree in science, engineering or related discipline is essential along with 3 years’ experience in a role within the biopharmaceutical/pharmaceutical industry
  • Demonstrated strong knowledge of ICH/GMP, data integrity, regulatory guidelines/directives, clinical supply chain processes and principles of Quality Assurance
  • Required to work on his/her own initiative in addition to working as part of a team. The candidate must be able to work across a team matrix in order to meet accelerated timelines.
  • Excellent communication, presentation and critical thinking skills are essential.
If this role is of interest, please apply now!
#LI-TB1


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