QA Manager & Responsible Person – GDP Compliance Leader

Danzas Corporation; Dublin; Vor Ort; EUR 90.000 - 120.000; Vollzeit

Benefits dieser Stelle

Free parking

Performance-based bonus

Pension scheme

GP consultations (24/7)

Zusammenfassung

DHL Supply Chain is seeking a QA Manager and Responsible Person (RP) to maintain the Pharmaceutical Quality Management System and ensure EU GDP and HPRA compliance for the Wholesale Distribution Authorisation.

You will act as named RP, oversee training, supplier approvals, recalls, deviations, CAPAs, and regulatory responses, while coordinating quality activities across the site to meet GDP standards.

Qualifikationen

• Bachelor's degree in a scientific/technical discipline.
• Experience as named RP on Wholesale Distribution Authorisation.
• Strong knowledge of EU GDP, HPRA requirements and pharmaceutical legislation.
• Experience with GDP compliance, audits and regulatory inspections.
• CSV experience within a GxP environment.
• Experience with temperature-controlled shipping and transport qualification.

Aufgaben

• Act as the named Responsible Person on the WDA and ensure GDP compliance.
• Maintain and oversee the Quality Management System.
• Ensure training programs and record accuracy.
• Approve deviations, investigations, CAPAs, change control and risk assessments.
• Lead regulatory inspections and respond to HPRA.
• Oversee supplier and customer approvals and recalls.
• Manage transport qualification and qualification activities.
• Coordinate recalls and quality issue resolutions.
• Maintain site compliance and regulatory licenses.

Kenntnisse

Leadership

Communication

Quality management

GxP experience

Problem solving

Regulatory know-how

Risk management

MS Office

Auditing

Ausbildung

Bachelor's degree in Pharmacy, Chemistry, Microbiology, Engineering, Life Sciences or related field

Tools

QMS (Quality Management System)

Jobbeschreibung

DHL Supply Chain is seeking a QA Manager and Responsible Person (RP) to maintain the Pharmaceutical Quality Management System and ensure EU GDP and HPRA compliance for the Wholesale Distribution Authorisation.

You will act as named RP, oversee training, supplier approvals, recalls, deviations, CAPAs, and regulatory responses, while coordinating quality activities across the site to meet GDP standards.