QA & Validation Officer

‘Be You’ at GSK At GSK, we're a company with a purpose to help people do more, feel better and live longer. We realise that our purpose starts with us. When we feel at our best, we perform at our best. Therefore, we want all applicants to be able to perform their best throughout the recruitment process. We will be delighted to hear from talented individuals that align to our values. These are at the heart of everything we do and include: Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. When you set out on your adventure at GSK, we make a deal. You commit to living our values and expectations and performing against our Innovation, Performance and Trust priorities. In return, GSK commits to providing the right environment for you to thrive. Together, we build an environment where we can all thrive and focus on what matters most to each of us. As a , we empower you to be yourself, share ideas and work collaboratively Job Title QA & Validation Officer In this role you will… Organise and lead validation activities Plan validation activities to ensure customer and business needs are met in alignment with the overall project plans and objectives Provide input, track and manage the Site Validation Master Plan in conjunction with the validation team. Write, review and approve validation lifecycle documentation and ensure they comply with EU GxP. Validation lifecycle documentation includes Validation Plans, interim / final Validation Summary Reports and Validation Review Reports Organise and lead Validation Working Parties to ensure all key stakeholders, including Qualified Persons, remain current with the validation status of new and updated equipment and processes Promote effective working relationships and ensure they are maintained through the validation working party Present validation activities and documentation during internal and external audits acting as a validation Subject Matter Expert Develop and continuously improve expertise linked to industry standard validation activities Our Pharmaceutical Supply Chain (PSC) business is responsible for making and supplying our pharmaceutical and biopharmaceutical products around the globe. The PSC organisation is involved with every production stage from the infrastructure of the manufacturing sites, supply forecasting, regulatory inspections, and the product’s quality. Why you?  Qualifications & Skills: Engineer Minimum HNC or equivalent in an appropriate scientific subject Good knowledge of GxP within a Pharmaceutical Environment Good knowledge of at least one or more of the following: Cleaning Validation Computer system / IT Validation and Serialisation Process Validation (including continuous verification) Complex Automation Validation Knowledge of the Change Control process Knowledge and application of the principle of the Quality Management System Effective communication skills and ability to communicate and influence at most levels of management Ability to build networks, to secure buy in and support for plans and ideas Develops new ideas and solutions about specific issues Proven track record of problem solving Qualifications & Skills: Degree in a scientific subject ZSC Divestment  It is GSK’s proposal to close its ZSC manufacturing operations once the technology transfer to the buyer is complete and the Manufacturing and Supply Agreement has come to an end, currently expected to be in 2025. At this time, and in the absence of any other alternative, GSK would be proposing to close the Ulverston site and to decommission the Barnard Castle ZSC buildings. GSK would explore all options for retraining, supporting employees who might be at the risk of redundancy. During the expected 3-5 years the successful candidate will be able to make a significant impact at ZSC and GSK. Whilst working at GSK you will be able to enjoy the excellent standard company benefits, in addition to being able to utilise the ZSC Training and Development workstream in helping you upskill towards your future career ambition and the ZSC Performance-Based Financial Recognition scheme to improve the lives of billions, join us at this exciting moment in our journey. Join our challenge to get Ahead Together. As a company driven by our values of Patient focus, Transparency, Respect and Integrity, we know inclusion and diversity are essential for us to be able to succeed. We want all our colleagues to thrive at GSK bringing their unique experiences, ensuring they feel good and to keep growing their careers. As a candidate for a role, we want you to feel the same way. 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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