Quality Specialist, 9-11 mth FTC

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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, ACO, 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.

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).

• 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.

• 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.
• 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

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.

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 morehere

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