At Amarin, you’ll make a difference.Our vision is to one day reach the moment when heart disease is no longer the #1 cause of death in Europe. Bold, we know. But it’s what drives us every single day. Knowing that because of what we do, someone, somewhere is less likely to have a heart attack or stroke. That’s making a real difference if you ask us.Even though we’ve been around for a while, in Europe, we’re starting from scratch. Building the organization, setting up the processes, educating people, delivering therapies. And we’re doing it in record time. In today’s life science industry, that’s unique. Some might even say “once-in-a-lifetime”.So if you’re looking for a company where you’ll be at the start of an amazing journey, a company that’s introducing a new era in cardiovascular care in Europe based on groundbreaking science, a company where you can really apply your experience, are empowered to innovate, where hard work is rewarded, and above all where you can make a true difference in people’s lives, Welcome!But let’s be perfectly clear, given our current start-up phase, the pressure is high. Resilience, flexibility, results-oriented and accountability aren’t vague notions here. We expect a lot from each other – and so we should. After all, patients count on us.And at Amarin, we also count on each other. Teamwork and collaboration are essential. We support each other, challenge each other and help each other. Across all functions and countries. We focus on moving forward, aren’t afraid of mistakes and leaders are just a (video) call away. Because we know that together, we achieve more. Working with some of the brightest in the industry, each as knowledgeable, determined and committed to our vision as the next, you’ll achieve more too.Primary Objectives:Preparing and reviewing batch manufacturing records and laboratory testing records to support QA and QP certification and batch release.Supporting GMP batch manufacturing through quality oversight of Contract Manufacturing Organisations (CMOs).Management of quality systems such as Deviations, CAPA, Change Control, and Risk Management to ensure GxP compliance & escalation as appropriate.Management and coordination of quality document updates.Supporting the vendor qualification & management program.Monitoring of CMO performance indicators and reporting of quality metrics.Supporting the preparation of Product Quality Reviews, and other essential documents when required.Supporting data preparation for periodic management reviews.Participating and supporting self- inspections, supplier & internal audits as required.Managing and coordinating customer complaint investigations and ensuring timely closureSupporting the preparation, delivery and coordination of training.Operation and maintenance of the electronic Document Management system to ensure control of SOPs, records and other documents.Supporting the maintenance of the Quality Management System to ensure compliance to all relevant regulatory standards.Be a key member of company audit team during regulatory or customer audits.Working in close partnership with other cross functional teams to meet timelines and achieve business results.Supporting Wholesale Distributors Authorisation (WDA) and Active Substance Registration (ASR).Education/Training: BSc. Degree or equivalent in Life Sciences is required. Skill(s): Strong inter-personal skills including the ability to work effectively in a global team environment and to build collaborative relationships with peers and other stakeholdersHighly organized with the ability to multi-taskStrong time management skillsAbility to communicate effectively with all levels of management both verbally and in writingGood presentation skillsStrong experience working with electronic systems and IT platformsExperience:3-5 years QA or QC experience in pharmaceutical industry, preferably on-site manufacturing.Strong understanding of Quality Management Systems and GMP is required.Management of quality systems including deviations, change control, and CAPA.Batch documentation preparation and review supporting QP batch certification and release.Experience in using electronic Quality Management Systems.GDP experience an advantage but not essential.