Site Name: Ireland - Dublin Posted Date: Jan 20 2025 Team introduction The GSK QP Importation team (Trading Partner Quality) provides a service to the GSK Trading Partners to permit Importation and QP certification for release of GSK and ViiV finished products from outside of the EU into the EU and from outside the UK into the UK. The product scope managed by the QP Importation team currently include topical semi-solids, oral solids, solutions, suspensions, and sterile solution for infusion dosage forms manufactured in third country GSK and Contract manufacturing sites. Position Summary The Batch Release Specialist prepares product release dossiers for presentation to the QP Importation Qualified Persons (QPs). This involves review of batch manufacturing and packaging records, artwork, quality notifications, transportation and temperature records, sampling plans and test results. The role also includes escalation of issues to manufacturing sites, warehouse teams and logistics groups that arise from the reviews to support batch certification processes. The QP Importation team manages approximately 1000 batches per annum and this role is key to ensuring compliant release of batches. We create a place where people can grow, be their best, be safe, and feel welcome, valued, and included. We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme. We embrace modern work practises; our Performance with Choice programme offers a hybrid working model, empowering you to find the optimal balance between remote and in-office work. Discover more about our company wide benefits and life at GSK on our webpage Life at GSK | GSK In this role you will: Review batch and transport documentation, including Quality events such as deviations and consult with the manufacturing site and/or warehouse, and QPs to understand the impact of the deviation on product quality prior to release and certification – manage correspondence and communication between the parties to conclusion. Ensure records of batches certified are maintained, and dossiers and samples archived in accordance with local SOPs and GMP requirements. Liaise with the Importation warehouses and Testing Laboratories to ensure samples’ delivery, obtain testing data and work with laboratory to resolve any issues related to QC analyses of imported products. Conduct activities to support QP Importation processes related to quality oversight for importation, including: Periodic Quality Reviews for imported products. Generation and reporting of Key Performance metrics. Standard Operation procedures and technical report preparation, revision, and approval Conduct/participate in self-inspections and management monitoring activities. Present data on GSK’s behalf during regulatory inspections of importation operations. Effectively communicate with Supply Chain Hubs, GSK Local Operating Companies, manufacturing sites, External Supply managers and Importation warehouses to provide information on progress of release and certification, as required. Why you? We are looking for professionals with these required skills and attributes to achieve our goals: Educated to Irish Leaving Certificate or UK GCSE/A Level standard (or equivalent). Preferably holds university degree in a relevant science subject e.g., Pharmacy, Chemistry, Biology, General Science Preferably experienced in manufacturing site operations, batch record review, quality data review and operational quality requirements Understanding of quality management principles and documentation requirements for GMP compliance Working knowledge of GMP and GDP regulations Capable of working in multi-disciplinary teams across IT, Quality, External Supply, Global Logistics, Supply Chain and Manufacturing Proficient in use of Microsoft Office applications. Preferably experienced in use of SAP, Veeva Vault, GLAMS systems. Closing Date for Applications: 31st January 2025 (COB) Please take a copy of the Job Description, as this will not be available post closure of the advert. When applying for this role, please use the ‘cover letter’ of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application. We make and supply medicines and vaccines all around the globe and our teams own every production stage, from creating quality products at our manufacturing sites to designing effective supply forecasting and regulatory inspections; all powered by digital, data and analytics. We operate at impressive scale, producing over 2.3 billion packs of medicines and doses of vaccines in 2023. We continue to modernise, so we can launch even more new products at speed whilst continuing to deliver across our entire portfolio through our relentless focus on quality, safety, and service. The way we work will change. For some, the shift in technology and products will be revolutionary. Our R&D pipeline demands a new kind of supply chain, and we need the very best minds and capability to help us on our journey to make more complex products, harnessing the power of smart manufacturing technologies including robotics, digital solutions and artificial intelligence to deliver for patients. If you are interested in joining us, find out more: Annual Report 2023 Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology). Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. 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