Qualified Person

Qualified Person - 12-months - Ireland

One of the top 10 best companies to work in Ireland is looking for a Qualified Person for their large-scale new facility in Ireland. 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.

What you'll do: 

• Review and approve QA/QP procedures, training materials, and Quality Agreements.
• Support start-up activities, including Manufacturer/Importation Authorisation submissions and knowledge transfer.
• Perform QP release of Investigational Medicinal Products (IMPs) in line with regulatory requirements.
• Provide guidance during Health Authority GMP/GDP inspections and audits.
• Advise stakeholders on quality issue management and process improvements.
• Maintain Site Master File and oversee Manufacturer/Importation Authorisation updates.
• Ensure rapid communication of significant quality issues to senior management.
• Review and approve procedural documents and participate in cross-functional teams.
• Influence external regulatory environment through interactions with authorities and industry groups.
• Identify risk areas and contribute to global audit planning.
• Supervise QA personnel and champion continuous improvement initiatives.

What you'll need: 

• Degree in science, engineering, or related discipline.
• Extensive experience in biopharmaceutical/pharmaceutical industry quality roles.
• Eligibility to act as EU Qualified Person under Manufacturing/Importation Authorisation.
• Experience with QP release of IMPs (preferred) and Responsible Person on WDA (desirable).
• Strong knowledge of ICH/GMP, data integrity, regulatory guidelines, and clinical supply chain processes.
• Proven leadership and influence management skills in a global matrix environment.
• Excellent communication and stakeholder engagement skills.
• Commitment to fostering a culture of continuous improvement and compliance.

If this role is of interest, please apply now!

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