19 Biotechnology / Life Sciences jobs in Darlington

As a CSV Specialist you will provide QA and Validation support to Automation and IT projects. You will provide technical advice and Quality decision making to establish processes and controls that meet Regulatory, cGMP, and QMS standards. The role will also encompass oversight of Quality Assurance processes within projects e.g. change control, validation documentation, deviation handling, CAPA. In this role you will…

• Support project completion in line with established timescales, through collaboration with teams and cross functional stakeholders providing QA compliance leadership, active risk management, and problem solving.
• Plan validation activities to ensure customer and business needs are met in alignment with the overall project plans and objectives; accountable for the validation and validation maintenance for computerised systems associated with Processes, Facilities, Equipment, Automation, Manufacturing Execution Systems (MES) and IT systems.
• Support a continuous improvement culture
• Support Level 1 self-inspections
  
  Graduate level qualification in a relevant degree and/or a demonstrated track record in the pharmaceutical industry
• Previous relevant experience
• Excellent interpersonal skills, including the ability to work across the organisation, forming strong partnerships (on and off site) at a technical level, and interact/influence/negotiate effectively at all levels of management and peers.
• Ability to work well under pressure with tight timelines
• Ability to analyse complex data / information / scenarios and make rational, risk based decisions which are communicated and / or escalated clearly and confidently
• Knowledge and understanding of the GAMP, 21 CFR Part 11, Annex 11 and Data Integrity and familiar with a risk based approach to computer systems validation.
  
  GSK Barnard Castle is a key secondary manufacturing site and has invested heavily in industry 4.0 state of the art, bespoke equipment to support sustained new product introductions and volume increases, and as a key supplier of some of GSK's blockbuster products, the site contributes revenues of ~$2Bn annually., 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. GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law. 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., Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at https://openpaymentsdata.cms.gov

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. We embrace modern work practises; our Performance with Choice programme. Discover more about our company wide benefits and life at GSK on our webpage Life at GSK | GSK