Qualified Person

Summary: The role of Qualified Person in Dublin involves overseeing the certification and batch release of clinical supplies within a large-scale €1 billion project. The position requires strong knowledge of regulatory guidelines and quality assurance principles, as well as the ability to manage quality issues and support audits. This opportunity offers a chance to work with cutting-edge technology in a fast-paced environment. Candidates must be eligible to act as a Qualified Person and have relevant experience in the field.

Key Responsibilities:

• 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 Skills:

• 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

Salary (Rate): undetermined

City: Dublin

Country: Ireland

Working Arrangements: undetermined

IR35 Status: undetermined

Seniority Level: undetermined

Industry: Other