Quality Manager – GDP S11994

Job Title: Quality Manager – GDP

Salary: € Negotiable on experience

Location: West Dublin

Ref: S11994

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.

    Bona Fides

• Oversee client approval and ensure bona fides are established and maintained annually.

• Ensure copies of wholesale/manufacturing authorizations and GDP/GMP certificates are obtained, valid, reviewed, and maintained in English.

• Conduct independent verification checks on all bona fides.

    Documentation Responsibilities

Be responsible for relevant document procedures across the organisation and process including those related to:

• Product quality impact

• EMP process

• Controlled drugs

• Temperature monitoring and control

• Change control

• Deviation/CAPA management

• Quality management review etc.

    Training & Competence

• Ensure all staff handling medicinal products receive initial and ongoing GDP training Ensure all training is recorded and reviewed.

    Premises & Operations

• 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.

Regulatory Liaison

• 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.

For more information please send your CV to Hazel Whelan in confidence through the link.

Email Hazel@rplus.ie

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