Quality Specialist/DRP

Limerick
Permanent
Full-time

2 months ago

Quality Specialist/DRPOur people make the difference. Here at PHX Ireland, we strive to be a place for everyone - where each and every one of us can be our true, authentic selves, every single day.For us, individuality sparks new ideas, shapes new approaches and brings us powerful new perspectives. It’s the heartbeat of our innovation, creativity, and success. Which is why, at PHX Ireland, we don’t just embrace our differences – we celebrate them.Across United Drug, McCabes Pharmacy, and TCP Homecare, in every location and every role, the way we work makes us who we are – and that’s something we are really proud of. Which is why we’ve summed up our ethos in our six PHX Ireland values; Customer focused, Quality driven, collaborative, ambitious, innovative, and inclusive.Overview/Purpose of the roleAs Deputy Responsible Person (DRP), the role supports the Responsible Person in ensuring full compliance with EU and HPRA Good Distribution Practice (GDP) guidelines for pharmaceutical secondary wholesale activities, acting as the designated RP in their absence. The position is responsible for maintaining and continuously improving the company’s ISO 9001:2015-certified Quality Management System, conducting audits, managing CAPAs, and ensuring ongoing regulatory compliance. The role also leads lean management initiatives to enhance operational efficiency and reduce waste across quality processes. As an SAP super user, the role provides frontline system support, training, and process optimization to ensure accurate data management and streamlined operations.Key ResponsibilitiesQuality Management (Pharmaceutical Secondary Wholesale):

Ensure compliance with Good Distribution Practice (GDP) and all regulatory requirements related to the secondary wholesale of pharmaceutical products. Maintain and continuously improve quality systems to ensure product integrity and patient safety.

Deputy Responsible Person

Assist the RP in ensuring that the company operates in full compliance with EU GDP (Directive 2013/C 343/01) and local regulatory requirements.
Act as the designated Responsible Person during periods of absence, ensuring continuity of compliance and oversight.
Support the implementation, maintenance, and improvement of the Quality Management System (QMS), including documentation, training, deviations, CAPAs, and change control processes.
Oversee and monitor product storage, transportation, and handling activities to ensure they meet GDP requirements, including temperature monitoring and calibration of equipment.
Ensure that all suppliers and customers are approved in accordance with company procedures and regulatory standards.
Participate in self-inspections, corporate audits, and inspections, and ensure timely resolution of findings.
Support training and competency assessments for staff involved in GDP activities.
Review and approve quality documentation, including SOPs, deviations, complaints, and returns.
Contribute to risk assessments and quality reviews, ensuring continuous improvement and operational efficiency.
Liaise with national regulatory authorities as required, and ensure that records and reporting obligations are maintained and fulfilled.

ISO 9001:2015 Compliance:

Manage and maintain the company’s ISO 9001:2015 Quality Management System. Conduct internal audits, support external audits, and drive corrective and preventive actions to ensure continued certification and performance improvement.

Lean Management:

Apply lean principles to improve operational efficiency, reduce waste, and optimize quality processes.
Lead or participate in continuous improvement initiatives to enhance productivity and cost-effectiveness.

SAP Super User:

Serve as the primary point of contact for SAP-related issues within the department. Provide user support, training, and system enhancements.
Collaborate with IT and business stakeholders to streamline processes and ensure data accuracy and integrity.

Qualifications and Experience

Degree in Pharmacy, Life Sciences, or a related field (Pharmacist registration may be required in some jurisdictions).
Minimum 3 years' experience in pharmaceutical wholesale distribution, quality assurance, or regulatory affairs.
In-depth knowledge of EU GDP guidelines and relevant national regulations.
Experience with Quality Management Systems (QMS) and regulatory audits/inspections.
Strong attention to detail, organization, and communication skills. Desirable:
Experience with ISO 9001:2015, Lean principles, or continuous improvement projects.
Familiarity with SAP or other ERP systems.
Certification or training related to GDP or Quality Management.

United Drug

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