QA Manager & Responsible Person

DHL Supply Chain; Dublin; In loco; Confidential; Tempo pieno

Vantaggi offerti da questo lavoro

Free parking

On-site canteen

Performance-based bonus

Pension scheme

GP consultations (24/7)

Descrizione del lavoro

DHL Supply Chain in Dublin seeks a QA Manager and Responsible Person to oversee the Pharmaceutical Quality Management System and ensure EU GDP compliance and HPRA requirements.

You will act as the named RP on the Wholesale Distribution Authorisation, manage training, recalls, supplier approvals and regulatory inspections while leading QA activities and driving continuous improvement.

Competenze

• Bachelor’s degree in Pharmacy, Chemistry, Microbiology, Engineering, Life Sciences or another relevant scientific/technical discipline.
• Appropriate qualifications, knowledge and experience to fulfil the requirements of a Responsible Person under GDP and HPRA expectations.
• Previous experience as a named Responsible Person on a Wholesale Distribution Authorisation is essential.
• Strong working knowledge of EU GDP Guidelines, HPRA requirements and pharmaceutical wholesale distribution legislation.
• Experience maintaining and providing oversight of a pharmaceutical Quality Management System.

Mansioni

• Act as a named Responsible Person on the Wholesale Distribution Authorisation and fulfil RP responsibilities under EU GDP requirements.
• Ensure GDP compliance demonstration and public service obligation fulfilment by the distributor.
• Maintain a Quality Management System and manage authorised activities and records.
• Coordinate and perform recalls for medicinal products and manage customer complaints.
• Approve subcontracted activities impacting GDP and oversee deviations, CAPAs, change controls and risk assessments.
• Monitor quality performance, trends, KPIs and participate in Quality Management Review activities.
• Provide leadership and communication with site team on QA and Validation requirements.
• Support regulatory inspections and regulatory responses as needed.

Conoscenze

Leadership

Quality management

Regulatory compliance

GDP knowledge

HPRA experience

Auditing

Problem solving

Communication

Risk management

Formazione

Bachelor’s degree in Pharmacy

Strumenti

MS Office

Descrizione del lavoro

Grade: K
Contract Type: Permanent (Full-Time), On-Site
Shift patterns: Mon to Fri,8:00 to 16:30
Location: Dublin

Think you know DHL? Think again! We're not just about delivering parcels. DHL Supply Chain is the world's leading logistics company and our people are the unsung heroes who keep the cogs turning and the country running smoothly.

We're now looking for a QA Manager and Responsible Person (RP) who will beresponsible for maintaining and overseeing the Pharmaceutical Quality Management System and ensuring ongoing compliance with EU Good Distribution Practice (GDP), HPRA requirements and the Wholesale Distribution Authorisation (WDA).

A TYPICAL DAY MAY INVOLVE

• Act as a named Responsible Person on the Wholesale Distribution Authorisatio and fulfil the responsibilities assigned to the RP under EU GDP requirements.
• The Responsible Person should carry out their duties in such a way as to ensure that the wholesale distributor can demonstrate GDP compliance and that public service obligations are met.
• The Responsible Person should carry out their duties in such a way as to ensure that the wholesale distributor can demonstrate GDP compliance and that public service obligations are met.
• The responsibilities of the Responsible Person include:

1. Ensuring that a Quality Management System is implemented and maintained.
2. Focusing on the management of authorised activities and the accuracy and quality of records.
3. Ensuring that initial and continuous training programmes are implemented and maintained.
4. Coordinating and promptly performing any recall operations for medicinal products.
5. Ensuring that relevant customer complaints are dealt with effectively.
6. Ensuring that suppliers and customers are approved.
7. Approving any subcontracted activities which may impact on GDP.
8. Ensuring that self-inspections are performed at appropriate regular intervals following a prearranged programme and that necessary corrective measures are put in place.
9. Keeping appropriate records of any delegated duties.
10. Deciding on the final disposition of returned, rejected, recalled or falsified products.
11. Approving any returns to saleable stock.
12. Ensuring that any additional requirements imposed on certain products by national law are adhered to.

• Sign and approve SOPs and other applicable Quality documentation within the scope of responsibility.
• Act as a key Quality contact for the HPRA and supportAC/lead regulatory inspections, regulatory responses, commitments and inspection-readiness activities.
• Maintain oversight of applicable regulatory licences, authorisations and site compliance requirements.
• Review and approve, as applicable, deviations, investigations, CAPAs, change controls and risk assessments, ensuring effective root-cause investigations and appropriate corrective and preventive actions.
• Monitor Quality performance, trends and KPIs and contribute to Quality Management Review activities.
• Review and approve Quality/Technical Agreements, where applicable.
• Ensure appropriate escalation and timely resolution of significant Quality, regulatory and compliance issues and promote continuous improvement.
• Provide Quality oversight of temperature-controlled shipper qualification, including active and passive shipping systems, where applicable.
• Support and/or approve transport lane qualification and transport qualification activities.
• Provide Quality oversight of qualification and validation activities including, where applicable, DQ, IQ, OQ, PQ, periodic review and requalification.
• Control of contractor costs
• Budget Management
• Continuous improvement
• OMS, HSMS and DPM implementation
• Ability to create requirements documents, SOPs, etc..
• Manage communication with the site team on QA and Validation requirements and processes
• Liaise with the planning departments in relation to resource availability
• Provide leadership to other colleagues in relation to the organisation of achieving site and company objectives.
• Identify potential, nurture development, and create a leadership succession path.

THIS ROLE WOULD SUIT PEOPLE WHO

• Bachelor's degree in Pharmacy, Chemistry, Microbiology, Engineering, Life Sciences or another relevant scientific/technical discipline.
• Appropriate qualifications, knowledge and experience to fulfil the requirements of a Responsible Person under applicable GDP legislation and HPRA expectations.
• Previous experience as a named Responsible Person on a Wholesale Distribution Authorisation is essential.
• Strong working knowledge of EU GDP Guidelines, HPRA requirements and pharmaceutical wholesale distribution legislation.
• Demonstrated experience maintaining and providing oversight of a pharmaceutical Quality Management System.
• Strong practical experience with deviations, investigations, CAPAs, change control, risk management, complaints, recalls and supplier/customer qualification.
• Experience supporting and preferably leading HPRA or other regulatory inspections and customer audits.
• Demonstrated experience in CSV within a GxP environment.
• Experience with temperature-controlled shipper qualification and/or validation.
• Experience with transport qualification, including temperature controlled pharmaceutical distribution.
• Understanding of temperature mapping and qualification of pharmaceutical storage facilities and equipment.
• Strong risk-based decision-making, problem-solving and investigation skills.
• Strong communication, leadership and stakeholder-management skills.
• Ability to make independent Quality decisions and effectively challenge activities where GDP compliance or product quality may be at risk.
• Excellent organisational and time-management skills.
• Good analytical skills
• Excellent interpersonal, leadership, motivational and planning skill
• Computer literate (minimum intermediate level on use of MS Office elements)
• Ability to think proactively
• People Management
• Life Science logistics industry experience
• Formal GDP / Responsible Person training from a recognised training provider.
• Demonstrable knowledge of EU GDP Guidelines, HPRA requirements and applicable pharmaceutical wholesale distribution legislation.
• Relevant training/qualification in GxP validation, Computerised System Validation, temperature-controlled shipper qualification and/or transport qualification is desirable.
• Auditor/Lead Auditor, Quality Management, pharmaceutical validation or other relevant Quality/GxP certification is advantageous.
• Proficient in Microsoft Office and relevant quality and warehouse management systems.

WHY JOIN US?

• Free parking and on-site canteen
• Performance-based bonus
• Generous pension scheme
• Free confidential 24/7 GP consultations
• Hundreds of retail and lifestyle discounts
• Financial wellness support

WHO WE ARE

We're the global leaders in supply chain management with 188,000 people in over 50 countries. Our expert teams work together to deliver for our customers across a range of industries including retail, automotive, healthcare and more.

BUILDING AN INCLUSIVE WORKPLACE

At DHL, we're all about creating a workplace where everyone's skills and experiences matter, and where you can be your true self every day.

Please be aware that interviews are provisionally scheduled to take place during the week commencing29th Oct 2026. Applications received after this date may not be considered but will be added to our talent pool for future opportunities, subject to your consent. Please also be aware that we review applications continuously and where we have a large number of applications the application period may close ahead of the provisional interview date. To ensure your application is considered we recommend submitting it as early as possible.

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