Site Name: UK - North Ayrshire - Irvine Posted Date: Dec 20 2024 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 centre 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 a Quality Validation Specialist, you will Lead and support the validation and life-cycle maintenance of site computer systems and analytical equipment in line with Site, GSK and regulatory requirements. Support the wider GSK network in the computer systems area. 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. Discover more about our company wide benefits and life at GSK on our webpage Life at GSK | GSK In this role you will Co-ordinate and lead the validation and life cycle maintenance of site computer systems, analytical equipment, and temperature-controlled storage facilities on site, as appropriate to ensure there is no break in the supply chain thus supporting Site and GSK objectives. Coordinate, lead, and support the compliance activity in preparation for any regulatory audit and in response to current and any subsequent legislation affecting computer systems validation, analytical equipment validation, electronic records, and electronic signatures. This involves an approval and advisory role with respect to assessments and follow-up corrective actions. Support standardisation of computer systems and analytical equipment validation processes, supporting training and adherence to these standard validation processes to deliver consistency and agility with cost benefits. To understand the impact on ways of working relevant to Computer Systems and Analytical Equipment validation as required through changes in legislation. Support the delivery of innovative strategies that are implemented by co-ordinating appropriate validation standards without adding significant cost to the business ensuring continuous improvement and long-term viability. Act as Subject Matter Expert (SME) for computer system and analytical equipment regulations. Why you? Basic Qualifications & Skills: We are looking for professionals with these required skills to achieve our goals: Degree or HND in HND level qualification or equivalent in either a Science or Engineering subject. Expert knowledge of validation in alignment with QMS, cGMP, GQLP and cGxP requirements. A broad multi-disciplined knowledge of computer hardware, software, relational databases, and other technology systems. Requirements. Experience in a regulated, quality driven process environment. broad multi-disciplined knowledge of computer hardware, software, relational databases, and other technology systems. Preferred Qualifications & Skills: Please note the following skills are not necessary, just preferred, if you do not have them, please still apply: 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, Kneat. Good planning, organisational and time management skills along with an ability to make decisions, solve problems, negotiate, influence, and communicate with others is required. Closing Date for Applications – 9th 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. 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. The helpline is available from 8.30am to 12.00 noon Monday to Friday, during bank holidays these times and days may vary. 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. Click the link and scroll to the Careers Section where you will find answers to multiple questions we receive . As you apply, we will ask you to share some personal information which is entirely voluntary. We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions. We would really appreciate it if you could take a few moments to complete it. 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