We have a
Qualified Person
position working for a
Biologics company
in the
west of Ireland
.
Reporting to the
Quality Manager, the Qualified Person (QP)
will be accountable for providing strong
Quality Assurance
oversight of
commercial vaccine products
.
This role is responsible for quality oversight and batch certification of finished products within the scope of the company's Manufacturing and Importation Authorisation (MIA), as well as for fulfilling all statutory duties of the
Qualified Person
in accordance with applicable
EU regulations.
Overview of your responsibilities
Ensure each commercial batch is manufactured, tested, and released in compliance with Irish law, the relevant Marketing Authorisation (MA), EU GMP, and Annex 16 requirements
Fulfil the ethical, professional, and legal responsibilities of the Qualified Person in line with EU Regulations
Maintain in-depth knowledge of all GMP manufacturing steps under QP responsibility for batch certification
Verify the end-to-end supply chain and robustness of pharmaceutical quality systems through final batch certification, including materials, packaging, and critical suppliers, using audit and risk-based approaches
Confirm all manufacturing, testing, and certification sites comply with the MA and operate in line with approved processes
Ensure all required audits of manufacturing and testing sites, including active substance manufacture, are completed and available prior to batch certification
Confirm all post-marketing regulatory commitments related to manufacturing or testing have been fulfilled
Knowledge, Skills and Experience Required for the Role
Prior experience as a named Qualified Person (QP) at a licensed facility preferred
Background in sterile manufacturing and/or biotechnology preferred
Strong working knowledge of cGMP in manufacturing and testing environments
Clear, accurate technical and compliance-focused writing skills
People management or supervisory experience preferred
Experience supporting regulatory inspections and internal GMP audits
Proven ability to manage stakeholders and elevate issues appropriately
For a confidential discussion and more information on the role contact
Courtney Russell
.
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