Quality Specialist, 9-11 mth FTC

Description Overview

The QA Specialist is responsible for ensuring compliance of the Perrigo Supply Chain International DAC International and affiliates organisation and activities with the general conditions of the Marketing Authorisation Holder (MAH) and of the Wholesale Distribution Authorisation (WDA), Active Substance Registration (ASR) and applicable current requirements of Good Distribution Practice (GDP) and current Good Manufacturing Practice (cGMP).

Scope of the Role

• Responsible for day-to-day activities designed to maintain and enhance the Quality Management System.
• Support quality systems on site such for the raising of Change Controls, Non-Conformances, Temperature excursions, CAPAs as required
• Support New Product Introductions (NPI) as applicable
• Maintenance of approved product, supplier and customer listings and supply chain maps
• Receipt and Management of temperature excursions and service complaints including maintenance of KPIs
• Logging and escalating Product Quality Defects, AEs, or Product Enquiries to the Complaints Team
• Liaising with the authorities for product quality defects and collating the required information/data as requested by the authorities
• Supplier and Customer qualification and maintenance including annual bona fides and monthly GMDP compliance checks
• Support during Quarantine, Field Actions and Recall activities
• Host or support the scheduled KPI meetings (Quality, logistics, planning) to maintain compliance to the QMS and implement continuous improvements as required
• Support or where necessary lead Quality based projects including working as part of a multidisciplinary team as required.
• Participation in the self-inspections, internal and regulatory audits and ensuring necessary corrective actions are put in place.
• Support/Drive the monthly affiliate meetings
• Support and participation in the PSCI Management Review.
• Flexibility to take on additional tasks and responsibilities at the discretion of the Head of Quality central Distribution QP & RP.

Experience Required

• Minimum of 3-5 years’ experience in GDP/GMP environment or quality role in a pharmaceutical setting.
• Ideally experience working in a QA team/environment
• Experience using electronic documentation systems e.g., Trackwise, OpenText, Pilgrim, PLM
• Experience in the use of standard business applications such as the Microsoft Office Suite.
• Experience in the use of root cause analysis and CAPAs in the investigation and resolution of deviations.
• Project Management skills
• Demonstrates good knowledge of ICH, EU, DAFM, BRC, Organic and HPRA GDP/GMP regulations
• Demonstrates good knowledge of the MDD and MDR
• Experience in using an ERP system such as SAP
• Training on the applicable internal processes and procedures