Qualified Person

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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