Quality Manager - GDP

RecruitmentPlus; Dublin; On-site; EUR 90,000 - 120,000; Full time

Job summary

RecruitmentPlus is seeking a Quality Manager and RP for a dynamic, growing healthcare distributor in Ireland. The role requires GDP experience, HPRA guidelines familiarity, and the ability to oversee QA systems and RP responsibilities for the wholesale of medicinal products.

The successful candidate will ensure GDP compliance across premises, CAPAs, audits, and changes; maintain continuity of supply during emergencies; act as HPRA liaison and drive continual improvement within WDA and regulatory

Qualifications

• 8+ years QA experience in distribution/logistics.
• Experience in HPRA/EU GDP regulated organisations.
• Thorough knowledge of temperature-controlled activities.
• Strong understanding of GDP and EU regulatory requirements for medicinal wholesaling.

Responsibilities

• Oversee QA systems to ensure GDP compliance.
• Act as Responsible Person (RP) and main HPRA liaison.
• Manage CAPAs, audits, complaints and close-outs.
• Ensure premises are suitable for GDP compliance.
• Maintain procedures and training up to date across GDP activities.
• Support continuity of supply during emergencies.

Skills

QA management

GDP knowledge

HPRA guidelines

Temperature-controlled

Job description

Quality Manager and RP required for a dynamic and growing healthcare distributor. Our client supplies a range of specialist medicines and medical products into hospital pharmacies nationwide and has had excellent growth over the last 5 years. They are now seeking an experienced healthcare QA Manager with GDP experience to act as Quality Manager and Responsible Person (RP) for the organisation.

This could be an excellent opportunity for an experienced Senior Quality Specialist to step up to a Quality Manager role. Extensive experience in Good Distribution Practice and knowledge of HPRA guidelines (IA-G0046) is essential.

Requirements

• Ideally 8+ years Senior QA experience in a distribution and logistics environment.
• Previous experience in a HPRA/EU GDP regulated organisation.
• Thorough knowledge of temperature-controlled activities.
• Thorough knowledge of Good Distribution Practice and global regulatory requirements in respect to the wholesaling of medicinal products.

Duties and Responsibilities

The Responsible Person (RP) ensures that systems and processes are in place to comply with Good Distribution Practice and current HPRA guidelines. The RP ensures procedures and training are maintained and up to date across all GDP activities.

The RP must also ensure the company honours its public service obligation to maintain continuity of supply, including during emergencies or disasters such as pandemics.

This role will be responsible for the full range of QA and RP obligations including:

Quality System Oversight and Regulatory Compliance

• Ensure compliance with the Wholesale Distribution Authorisation (WDA), HPRA Guidelines and all relevant HPRA guides and legal requirements.
• Ensure compliance with EU GDP guidelines.
• Ensure an effective Quality System is implemented and maintained.
• Ensure the WDA holder conducts only authorized GDP activities.
• Ensure all aspects of premises are suitable and maintained for GDP compliance.
• Act as decision-maker for non-conformances, CAPAs, complaints, and audit close-outs.
• Identify opportunities for process improvement.
• Act as main point of contact with HPRA.
• Notify HPRA of changes to facilities, RP, or products.
• Stay updated on HPRA guides, forms, legal requirements, and regulatory changes.