Quality and Regulatory Specialist

Quality and Regulatory SpecialistPostulerlocations: Cork, Irelandtime type: Temps Pleinposted on: Publié aujourd'huitime left to apply: Date de fin : 13 juillet 2026 (Il reste 12 jours pour postuler)job requisition id: RCherchez-vous à faire une différence dans la vie d'un patient? Chez AmerisourceBergen, vous trouverez une culture innovante et collaborative, axée sur le patient et soucieuse de faire la différence. En tant qu'organisation nous sommes unis par notre responsabilité d'œuvrer pour des vies plus saines. Joignez-vous à nous et postulez dès aujourd'hui!# Ce que vous ferez # About the Role This role is in support of BluePoint Laboratories, a Cencora business offering a trusted source of generic pharmaceuticals.This is a fantastic opportunity in a role that blends hands-on Quality Assurance with Regulatory Affairs, giving you the chance to grow across both disciplines at the same time. The product portfolio is constantly evolving, from pharmaceuticals and medical devices to exciting emerging areas like biosimilars, so there is always something new to get involved in.As a virtual operation, you will collaborate with colleagues across multiple countries, bringing real international exposure to your day-to-day work. A structured training plan is in place to set you up for success from day one. Location : Little Island, Cork Shift Pattern : 39 hours per week, Monday to Friday Working Model : Hybrid, 2 to 3 days on-site, with the remainder from home Key Responsibilities Ensure ongoing compliance with cGMP, Environmental, Health and Safety regulations Execute all Quality Management System activities including non-conformances, deviations, change control, complaints, CAPA, document control and record retention Manage and execute the finished product non-conformance process and support timely product release Lead regulatory updates to product labelling, ensuring compliant and timely product launches Create and maintain National Drug Codes (NDC), Universal Product Codes (UPC) and Structured Product Labelling (SPL) for FDA submissions Ensure company and product registration is maintained in all appropriate markets and with relevant regulatory agencies Review and approve product labelling, patient package inserts and associated documentation Develop, implement and maintain Standard Operating Procedures (SOPs) Monitor Key Performance Indicators (KPIs) to track performance and identify opportunities for improvement Stay current with evolving regulatory trends and requirements Promote and maintain a safe, healthy working environment. Skills and Experience Essential: Minimum BSc in a scientific discipline (e.g. Chemistry, Biology or related field) At least 5 years' experience in a Quality Assurance role within a cGMP environment Experience with CAPAs, deviations, change control and other core QMS processes Strong background in the pharmaceutical industry, ideally within a manufacturing setting Excellent written and verbal communication skills with strong attention to detail Proven ability to work both independently and collaboratively across cross-functional teams Strong problem-solving and critical thinking skills Proficient in Microsoft Office (Excel, Word) and Document Management Systems Desirable: Experience in Regulatory Affairs, particularly around labelling and submissions Familiarity with Medical Device regulations Experience with Artwork review and/or Supplier Quality What's on Offer Competitive salary Annual performance bonus Private healthcare coverage Company pension scheme A genuinely varied role combining Quality Assurance and Regulatory Affairs in one position International exposure through a virtual, cross-country working environment Structured onboarding and training plan to support your success from day one Opportunities to work on exciting new product areas, including biosimilars Ce qu'Cencora offre Nous offrons une rémunération globale concurrentielle. Notre engagement envers nos associés comprend l'offre de programmes d'avantages sociaux complets, diversifiés et conçus pour répondre aux divers besoins de l'ensemble de nos associés. Grâce à notre présence mondiale et nos diverses unités commerciales, nous avons une approche équilibrée des avantages que nous offrons. De nombreux avantages sociaux sont payés par l'entreprise, tandis que d'autres sont offerts par les cotisations des associés. Les offres d'avantages sociaux spécifiques peuvent varier selon l'emplacement, le poste ou l'unité d'affaires.Temps Plein