Operational Quality Advisor

Site Name: UK – North Ayrshire – Irvine Posted Date: Nov 27 2024 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 202 3 The Irvine factory holds a place of pride within a short distance of less than 20 miles from where Sir Alexander Fleming, the pioneer who discovered Penicillin, was born. Fleming inaugurated the Beecham research center in Surrey in 1947, which is renowned for being the birthplace of the Penicillin molecule. Established in 1973, the Irvine factory embarked on a novel journey in the pharmaceutical industry with the production of Penicillin G, marking a pivotal advancement in the global availability of semi-synthetic antibiotics. Now, over four decades later, the site remains a key manufacturing facility for GSK. At GSK Irvine, our production exceeds 2,500 tonnes of antibiotics annually, which is sufficient to treat 250 million patients through the penicillin supply network. The site specializes in producing key ingredients such as Potassium Clavulanate. As Operational Quality Advisor, you will be responsible for the release of raw materials, starting materials, intermediates, drug substance and blends. You will be key in the management and governance processes providing overall quality assurance. This is a 12-month secondment/contract position with possibility to extend or become a permanent role in the future. In this role you will… Participate in assessment of non-conformances with cGMP, deviations and customer complaints investigations and ensure that appropriate CAPA has been identified, and verification of CAPA effectiveness and deviation trending is carried out. Approve master batch sheets, SOPs, specifications and methods to ensure compliance with GMP and licence registrations. Participate in Operational Quality approval of changes in a compliant manner to ensure that proposed changes are planned and evaluated. Plan, conduct and document internal quality audits to ensure GMP compliance. Review of batch documentation, test results and all other documentation associated with certification (for EU) and release of Finished Product, provide Batch certification for release and Evaluate site Right First time . Review and approve of Technical Terms of Supply (TTS) and associated quality agreements to include review and approval of changes and assessment of deviations and trends and approve distribution risk assessments to assure compliance with cGMP. Why you? Qualifications & Skills: Degree or HNC/HND in relevant subject or equivalent experience, with relevant GMP experience Experience within the pharmaceutical industry including an in-depth knowledge of cGMP/GQLP and Quality issues Preferred: Organisational/decision making skills, excellent communication skills (both written and verbal) and an ability to manage change Experience of working in the GMP operational environment Experience in systems utilised in the role, such as SAP / M-ERP, VQMS. Application close date: 11th Dec 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. This ensures that all qualified applicants will receive equal consideration for employment without regard to neurodiversity, race/ethnicity, colour, national origin, religion, gender, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class*(*US only). We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are. Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on Ukdiversity.recruitment@gsk.com or 0808 234 4391. Please note should your enquiry not relate to adjustments, we will not be able to support you through these channels. However, we have created a UK Recruitment FAQ guide. 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