Site Name: UK - County Durham - Barnard Castle Posted Date: Nov 11 2024 Qualified Person Closing Date for Applications – 25th November (COB) GSK have a challenging and inspiring mission: to improve the quality of human life by enabling people to do more, feel better and live longer. The Quality function promotes quality and compliance through the product life-cycle in the manufacturing and production operations across GSK Sites. The team supervises all quality related systems, improvement procedures and documentation (including analytical data and information) to ensure products released have been manufactured and packaged according to all Regulatory and cGMP requirements (including appropriate certification for the UK/EU markets). An exciting opportunity has arisen for Qualified Person (QP) to join the Barnard Castle Inhalations and Dermatologicals business unit. As a QP you will review and certify finished products (batches) for release/onward progression (to market). QPs are responsible for ensuring that batches are manufactured in compliance with laws (for all the Member State where certification takes place) and in accordance with the requirements of marketing authorization (MA). All released products must conform to required quality standards (by reviewing appropriate documentation) and have been manufactured and packaged according to the regulatory dossier, Good Manufacturing Practice (GMP) and business requirements. Your QP qualification must be recognised in the UK. As this role is multi-faceted and collaborates with a wide variety of on-site production and operations teams, you will also be self-motivated with strong experience of working in quality at a sophisticated manufacturing site. You will be resilient and calm, with strong communication skills. The successful person will perform the quality assurance activities and quality oversight of the GMP functions performed. Key Responsibilities include, but are not limited to: Support an effective compliant product release service which ensures that all products QP released for sale or further processing have a quality appropriate to their intended use, i.e. comply with Company GMP Standards and Product Quality Specifications. Ensure quality oversight of site operations through formal quality meetings and support regulatory inspections, as required. Influence Quality Improvement programmes in conjunction with the appropriate product Stream operations and technical colleagues that will reduce rejects and customer complaints. Ensure that the Quality Leadership Team and other Business Unit Management (as applicable) are notified of any trends/changes or deviations from GMP, which may have significant effect on product quality. Provide GMP advice on an ongoing basis, as required. Why You? Required Qualifications and experience: Science degree and experience in pharmaceutical manufacturing and quality operations. Qualified Person (QP) stated on a current UK Manufacturer’s/Importer’s license. Membership of a professional body e.g. RSC, RPSGB, RSB. Experience within the pharmaceutical industry. Preferred Qualifications & Skills: If you have the following characteristics, it would be a plus: Experience with the certification of major dose forms (cream/ointments), aseptic sterile manufacture and biopharm products. Knowledge of current Good Manufacturing Practice (cGMP) requirements. Knowledge and application of the principle of the Quality Management Systems (QMS). 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. 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. 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