Quality and Compliance Administrator

Perrigo Company plc; Dublin; On-site; EUR 40,000 - 56,000; Full time

Job summary

Perrigo Company is seeking a QA Operations role (PSCI) to assist in compliance with MAH, MIA, WDA, ASR and GDP/GMP requirements. The role supports the QA team, updates PSCI maps, SOPs and work instructions, and manages documentation.

Responsibilities include handling deviations, distribution complaints, temperature excursions, CAPAs, and participation in internal and regulatory audits. Training on internal processes is provided; industry experience is not essential, and pursuing third level

Qualifications

• Experience with standard business applications such as MS Office Suite.
• Training on the applicable internal processes and procedures
• Industry experience not essential
• Pursuing third level education

Responsibilities

• Support the QA team with day-to-day activities to maintain and enhance the Quality Management System.
• Revising and uploading PSCI supply Chain Maps to reference the PSCI entity
• Revising Standard Operating Procedures and Work Instructions to reference the PSCI entity
• Documentation management including archiving, Sharepoint management, filing
• Supporting in the raising of Deviations, Distribution Complaints, Temperature Excursions, CAPAs as required
• Assist with revisions to the approved product, supplier and customer listings
• Assist in supplier and Customer/affiliate qualification and maintenance
• Independent verification checks of licences (EUDRA, MHRA, HPRA,FAGG…)
• Participation in self-inspections, internal and regulatory audits and ensuring corrective actions
• Flexibility to take on additional tasks at the Manager’s discretion
• Assist in effective implementation of the Quality Management System and continuous improvement

Education

Pursuing third level education

Tools

Microsoft Office Suite

Job description

Description Overview

The QA Operations role (PSCI) is responsible for assisting in the compliance of the Perrigo Supply Chain International DAC and affiliates organisation and activities with the general conditions of the Marketing Authorisation Holder (MAH), Manufacturing Importation Authorisation (MIA), Wholesale Distribution Authorisation (WDA), Active Substance Registration (ASR) and applicable current requirements of Good Distribution Practice (GDP) and current Good Manufacturing Practice

Scope of the Role

• Support the QA team with the day-to-day activities designed to maintain and enhance the Quality Management System.
• Revising and uploading PSCI supply Chain Maps to reference the PSCI entity
• Revising Standard Operating Procedures and Work Instructions to reference the PSCI entity
• Documentation management including archiving, Sharepoint management, filing.
• Supporting in the raising of Deviations, Distribution Complaints, Temperature Excursions, CAPAs as required.
• Assist with any revisions to the approved product, supplier and customer listings
• Assist in the supplier and Customer/affiliate qualification and maintenance
• Independent verification checks of licences (EUDRA, MHRA, HPRA,FAGG…)
• Participation in the self-inspections, internal and regulatory audits and ensuring necessary corrective actions are put in place.
• Flexibility to take on additional tasks and responsibilities at the discretion of the Manager.
• Assist in the effective implementation of the Quality Management System and facilitate the continuous improvement of same ensuring the Quality Management Systems are accurate and complete; review on a continuous basis.

Experience Required

• Experience in the use of standard business applications such as the Microsoft Office Suite.
• Training on the applicable internal processes and procedures
• Industry experience not essential
• Pursuing third level education