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Qualified Person

  1. Ireland, Dublin
Dublin
  1. Contract
Competitive
  1. Compliance / Quality Assurance
37115
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Qualified Person - Ireland, Dublin - 12 Month Contract 

One of the top 10 best companies to work in Ireland is looking for Qualified Person 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:
  • Qualified Person certification and batch release of clinical supplies
  • Acts as a Responsible Person on a WDA for Pre-Approval Access
  • Support for Health Authority GMP/GDP inspections and audits across the supply chain
  • Advise stakeholders on quality issue management and process enhancement/compliance
  • Incorporate global regulatory trends and changes into Supply Chain Quality
  • Manufacturers Authorisation update and maintenance
  • Ensure rapid communication of quality issues or significant deviations, to business partners and senior management
  • Review and approve procedural documents
Key requirements include:
  • Must be eligible to act as Qualified Person on the Manufacturing/Importation Authorisation
  • Previous experience as a Responsible Person on a WDA is preferred
  • Demonstrated strong knowledge of ICH/GMP, data integrity, regulatory guidelines/directives, clinical supply chain processes and principles of Quality Assurance
  • Proven track record of building/ maintaining high-performance teams/organisations and influencing/ motivating global teams to achieve results—delivering on business and program goals
  • Proven leadership / influence management skills
  • Proven clear communication supporting delivery for the business
If this role is of interest, please apply now!
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