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.
Ideal Candidate
Team Player
Communicative
Problem Solver
Detail-oriented
What You'll Do
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.
What You'll Need
QP qualified with at least 8 years' experience on a license
Solid experience in management of clinical trial supplies
Experience in management of unlicensed/unauthorised medicines preferred
Ability to be eligible for UK QP in the future would be an ideal candidate
Significant hands on experience with GMP manufacturing operations and batch certification activities
Ability to influence decisions and effective communicator
Ability to talk to clients confidently and understand their needs
Ability to work on own initiative
Adaptable and flexible towards work, using risk management effectively
Strong site based experience in quality control, quality assurance or manufacturing operations
Ability to remain in a statutory position for extended periods as part of normal day to day activities, with reasonable adjustments considered where appropriate.
What We Offer
Group Private Medical Insurance
Group General Life Assurance
Group Critical Illness and Group Income Protection
Salary sacrifice pension scheme
Enhanced maternity & paternity pay
Educational Assistance allowance
Paid volunteering day
WEP Clinical is a smoke free, drug free, and alcohol free work environment.
WEP Clinical is an equal opportunity employer.
WEP Clinical does not unlawfully discriminate against employees or applicants for employment based on an individual's race, colour, religion, creed, sex, sexual orientation, gender identity or expression, national origin, genetic information, age, disability, marital status, veteran status or any other status protected by applicable law.
This policy applies to all terms, conditions, and privileges of employment, including recruitment, hiring, placement, compensation, promotion, discipline, and termination.
WEP Clinical will make reasonable accommodation for qualified individuals with known disabilities, in accordance with applicable law.
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