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 as raising 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 authorities for product quality defects and collating required information/data as requested by 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 scheduled KPI meetings (Quality, logistics, planning) to maintain compliance to the QMS and implement continuous improvements as required.
* Support or lead Quality-based projects as part of a multidisciplinary team where required.
* Participation in self-inspections, internal and regulatory audits and ensuring corrective actions are implemented.
* Support/drive monthly affiliate meetings and participate in the PSCI Management Review.
* Flexibility to take on additional tasks and responsibilities as directed by 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 such as Trackwise, OpenText, Pilgrim, PLM.
* Experience with standard business applications (Microsoft Office Suite).
* Experience in root cause analysis and CAPAs in the investigation and resolution of deviations.
* Project Management skills.
* Good knowledge of ICH, EU, DAFM, BRC, Organic and HPRA GDP/GMP regulations.
* Good knowledge of the MDD and MDR.
* Experience using an ERP system such as SAP.
* Training on 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.
Working Arrangements
Hybrid Working Approach: we promote flexibility with the ability to work two days a week from home in many roles.
Additional Information
We are proud to be included in the Forbes list of "America\'s Best Employers by State 2024". 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.
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
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