At Perrigo, we are driven by our mission to Makes Lives Better Through Trusted Health and Wellness Solutions, Accessible to All. We are proud to be a Top 10 player in the European Consumer Self-Care market and the largest U.S. store brand provider of over the counter and infant formula. Dedicated to providing The Best Self-Care for Everyone, we are the people behind the brands you trust. We are Opill®, Compeed®, Solpadeine®, NiQuitin®, and many more. We Are Perrigo. We are committed to enhancing the wellbeing of our colleagues and consumers alike. We pride ourselves on fostering an inclusive, collaborative culture where each person can experience a sense of belonging.

Join us on our One Perrigo journey as we evolve to win in self-care.

Description Overview

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

This is a 12 month fixed term contract.

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/notified body audits and ensuring necessary corrective actions are put in place.
Support/Drive the monthly affiliate meetings
Support and participation in Management Review.
Flexibility to take on additional tasks and responsibilities at the discretion of the Head of Quality Central Distribution & Responsible Persons.

Experience Required

Essential:

Minimum of 2 years’ experience in GDP/GMP environment or quality role in a pharmaceutical setting.
Ideally experience working in a QA team/environment.

Desirable:

Experience using electronic documentation systems e.g., Trackwise, Veeva
Experience in the use of root cause analysis and CAPAs in the investigation and resolution of deviations.
Project Management skills
Demonstrates good knowledge of EU and HPRA GDP/GMP regulations
Demonstrates good knowledge of the MDD and MDR for Medical Devices
Experience in using an ERP system such as SAP
Training on the applicable internal processes and procedures

Benefits
We believe our people are our greatest asset. Alongside competitive compensation, we offer benefits tailored to supporting you and your family, as well as career development opportunities to ensure you feel valued and supported, both professionally and personally.

Find out more about Total Rewards at Perrigo.

Hybrid Working Approach
We love our offices and the setting they provide for in-person collaboration and celebration. But we also appreciate the opportunity to work remotely can energise you too, so we promote flexibility with the ability to work two days a week from home in many roles.

We are proud to be included in the Forbes list of "America's Best Employers by State 2024". Find out more here

Applicants please note: To apply to this position please click the APPLY button at the bottom of the application. (The SAVE button will only save your profile information but not submit an application for this open position.) Thank you.

We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or other characteristics protected by law. #weareperrigo

QA Specialist - 12 Month Fixed Term Contract

Benefits

Job Description