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QA Senior Specialist Compliance

  1. Ireland, Dublin
Dublin
  1. Contract
Competitive
  1. Compliance / Quality Assurance
37715
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QA Senior Specialist Compliance - Ireland, Dublin - 6 Months Contract

One of the top 10 best companies to work in Ireland is looking for a QA Senior Specialist Compliance 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:
  • Review and approve quality agreements.
  • Release incoming materials for use in manufacturing operations
  • Support qualification of new suppliers/materials and re-qualification of existing.
  • Assess supplier change notifications for impact to qualification status.
  • Support material certification and direct dispense programs.
  • Review and approve quality agreements.
  • Authoring, review and approval of QA-related procedures.
  • Support OpEx programs and champion continuous quality improvement initiatives.
  • QA review, assessment and approval activities for Biologics Manufacture, as applicable, for: Change controls, Deviations/Investigations, CAPAs, Other associated documentation
Key requirements include:
  • BSc in Science or related discipline with a minimum of 2 years’ Supplier Quality or related experience in a Biologics or Pharmaceutical environment.
  • A clear understanding of cGMP requirements for QA systems and compliance and/or manufacturing.
  • Detailed knowledge of Biologics Processing would be a distinct advantage.
  • Required to work on his/her own initiative in addition to working as part of a team.
  • Excellent communication, presentation, time management and organisational skills are essential.
If this role is of interest, please apply now!
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