Quality and Compliance Administrator

Biopharma Asia; Dublin; Remote; EUR 42,000 - 62,000; Full time

Job summary

Biopharma Careers is seeking a QA Operations professional (PSCI) to help ensure compliance with MAH, MIA, WDA, ASR, GDP and GDP-related requirements across Perrigo Supply Chain International DAC and affiliates.

The role supports the QA team in day-to-day activities to maintain and enhance the Quality Management System, including documentation management, revisions to maps and SOPs, supplier/customer qualification, and participation in audits and regulatory inspections.

Qualifications

• Experience using standard business applications (Microsoft Office Suite).
• Training on internal processes and procedures.
• Industry experience not essential.
• Pursuing third level education.

Responsibilities

• Revise and upload PSCI supply chain maps to reference the PSCI entity.
• Revise Standard Operating Procedures and Work Instructions to reference the PSCI entity.
• Manage documentation including archiving, SharePoint management, and filing.
• Support the raising of deviations, distribution complaints, temperature excursions, and CAPAs as required.
• Assist with revisions to approved product, supplier, and customer listings.
• Assist in supplier and customer/affiliate qualification and maintenance.
• Perform independent verification checks of licences (e.g., EUDRA, MHRA, HPRA, FAGG).
• Participate in self-inspections, internal and regulatory audits, and ensure corrective actions are implemented.
• Be flexible to take on additional tasks as directed by the Manager.
• Assist in the effective implementation and continuous improvement of the Quality Management System.

Skills

Microsoft Office Suite

Education

Pursuing third level education

Job description

Description Overview

TheQA 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