Site Name: UK - Hertfordshire - Ware Posted Date: Jan 9 2025 The Quality function promotes quality and compliance within the wider manufacturing and production operations at the GSK Ware manufacturing site. This includes monitoring all quality related equipment, processes, and systems (including data and information), drive improvement and ensure the appropriate records are in place and maintained and products released have been manufactured and packaged according to regulatory and cGxP requirements. Job Purpose: Reporting to the Site Validation Manager, as Validation Specialist you will be the site expert in one or more areas of validation, as well as managing validation activities to ensure they are compliant with regulatory requirements and aligned to Departmental and Site aims. Key Responsibilities: • To provide SME support to Validation, Inspection Readiness and Product Registration activities on site. • To ensure the execution of Validation/Qualification activities are aligned to Site and Team aims (and GSK standards). • To provide quality oversight to equipment, utilities, facilities and associated controls qualification and computerised systems ensuring the continuous maintenance of the validated status. • To author, review and approve validation plans, protocols, and reports. • To manage validation aspects of change controls including the review and approval of change control requests and associated assessments for impact to process, equipment, cleaning and/or utilities validation, as well as site compliance. • To manage continuous improvement initiatives associated to Validation/Qualification activities. • To be the site validation expert in one or more specialist areas of validation. • To set-up and manage cross-functional teams as validation working parties to confirm the validation scope for technical and engineering projects, ensuring the appropriate level of validation activities is built into project plans and executed to meet regulatory requirements. • To periodically audit process, equipment, cleaning and utilities validation activities for compliance to internal and external regulatory policies and guidelines. • To train, coach and supervise other validation team members as applicable. About You: As this role is multi-faceted and includes liaising with a wide variety of on-site production and operations teams, you will be a self-motivated person who has strong experience of working in technical and/or validation roles at a complex manufacturing site. You will be resilient and calm under pressure, with strong people skills and a proven ability to influence people to achieve and drive performance. You will have a strong continuous improvement mindset. During the application process, we are looking to see that applicants have a clear understanding of the complexities and importance of quality and validation activities within a pharmaceutical manufacturing site. About Ware Manufacturing Site: Medicines at Ware are presented as either Respiratory devices or in Oral Solid Dose form, and the site has circa 1,500 highly motivated and capable people working at it. The Ware site holds a unique position in our network as the only site responsible for launching the company’s pipeline of new medicines in oral and solid dose forms, as well as operating a high-volume commercial production for respiratory devices. CLOSING DATE for applications: Friday 24th of January 2025 (COB). Qualifications: BSc in Scientific or Engineering discipline or equivalent. Relevant Experience in Manufacturing working in Technical, Engineering, Manufacturing and/or Quality functions in the development, manufacturing, quality oversight, validation and/or maintenance of product from a highly regulated industry (e.g. pharmaceuticals). Advanced knowledge of at least one of the following: Equipment Validation Facility Validation Cleaning Validation CSV/IT Validation Process Validation Practical experience in the use of SAP, Veeva and Kneat systems is advantageous. Benefits: GSK offers a range of benefits to its employees, which include, but are not limited to: • Competitive base Salary • Annual bonus based on company performance • Opportunities to partake in on the job training courses • Opportunities to attend and partake in industry conferences • Opportunities for support for professional development • Access to healthcare and wellbeing programmes • Employee recognition programmes If you would like to learn more about our company wide benefits and life at GSK we would suggest looking at our webpage Life at GSK | GSK. 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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