Wepclinical1mo ago

Qualified Person

Ireland·DublinFull-Timemid

Other

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Quick Summary

Overview

Are you seeking an exciting and fulfilling new opportunity? Join our dynamic team at WEP Clinical,

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Are you seeking an exciting and fulfilling new opportunity? Join our dynamic team at WEP Clinical, where your contributions will play a key role in driving impactful solutions and improving outcomes for clients and patients. We encourage innovation and collaboration, challenging our team to bring forward ideas that make a real difference. Be part of a mission-driven organisation dedicated to advancing clinical research and transforming lives.

Role Objectives:

The Qualified Person (QP) is accountable for ensuring that all medicinal products handled, packaged, released, and distributed from the Dublin facility, as part of WEP Clinical’s broader GMP operations, comply with applicable EU GMP and relevant regulatory requirements.

The QP will be responsible for batch certification of unlicensed medicines and investigational medicinal products intended for clinical trial, ensuring patient safety, product quality, and regulatory compliance. The role also supports core GMP quality operations across WEP Clinical activities and contributes to inspection readiness, quality oversight, and the continued development of GMP capabilities to support operational growth.

Team Player

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Problem Solver

Detail-oriented

Perform QP duties in accordance with EU GMP (Annex 16), EU Directives/Regulations, and Irish legislation.

Certify medicinal products including IMPs, AMPs, and unauthorised/exempt medicines.

Ensure QP certification aligns with EU GMP, EU Clinical Trials Regulation/Directive, IMPDs, PSFs, protocols, local authorisations, and Quality Agreements.

Perform and document import GMP verification for products from third countries.

Ensure products are manufactured to EU/EEA GMP standards and regulatory expectations.

Verify supply chain compliance in line with approved Quality Agreements.

Maintain the QP Register for Compassionate Use and Clinical Trial batches.

Review supply chain, product-level, and batch-level documentation (e.g. audit reports, IMPDs, validation data, batch records, transport records).

Support development and approval of Product Specification Files (PSFs).

Oversee manufacturing, packaging, testing, and importation activities, including outsourced operations.

Review and approve Quality Technical Agreements and support QMS activities (deviations, CAPAs, change controls, complaints).

Support inspections (including HPRA), client interactions, and drive continuous improvement in GMP and QP release processes