Walker Cole International is searching for a Quality Assurance Manager, GDP / Responsible Person (RP) to join a growing pharmaceutical organisation as they establish and expand their Irish operations. This is a key quality leadership role, combining named RP responsibilities with oversight of GDP quality systems and third-party distribution activities.
All the relevant skills, qualifications and experience that a successful applicant will need are listed in the following description.
The candidate should be based in Ireland, but the role can be done remotely.
You will be responsible for:
* Acting as the named Responsible Person (RP) on a Wholesale Distribution Authorisation, ensuring compliance with EU GDP (2013/C 343/01) and HPRA requirements.
* Managing and maintaining the GDP Quality Management System (QMS), including deviations, CAPAs, change control, risk management and quality metrics.
* Leading inspection readiness activities and supporting regulatory inspections, audits and recall simulations.
* Providing quality oversight of third-party storage, distribution and supply chain partners, including quality agreements and supplier qualification.
The successful candidate will have:
* A degree or equivalent qualification in a scientific or related discipline.
* Eligibility to act as a Responsible Person under EU GDP requirements in Ireland.
* Proven experience in a GDP-regulated pharmaceutical environment, with hands-on responsibility for QMS, audits and third-party oversight. xyswxtq
* Strong working knowledge of EU GDP and HPRA guidance, with a pragmatic, risk-based approach to quality and stakeholder management.
Quality Assurance Manager | Quality Manager | Responsible Person | RP | GDP | Good Distribution Practice | EU GDP | HPRA | Pharmaceutical | QA | QMS | CAPA | Change Control | Supplier Management | Distribution | Supply Chain | Regulatory | Dublin | Hybrid | Remote