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Job Title: Validation Consultant

Location: Remote / Home-based

Overview

GSK is a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. We are on an audacious journey to impact the health of 2.5 billion people over the next decade. Our R&D division is at the forefront of this mission, dedicated to the discovery and development of groundbreaking vaccines and medicines. We are transforming the landscape of medical research by integrating cutting-edge science and technology and harnessing the power of genetics and new data. By fostering a collaborative environment that unites the talents of our people, we are revolutionizing R&D to pre-empt and defeat diseases. Join us in our commitment to uniting science, technology, and talent to get ahead of disease together.

Role Overview

GSK are looking for a Validation Consultant to join the team. This person will provide quality assurance oversight for the validation, deployment, maintenance and inspection readiness of complex GxP computerised systems, ensuring compliance with pharmaceutical manufacturing and distribution regulations while supporting global projects across validation, risk management and continuous improvement activities. The Validation Consultant will bring strong experience in computer systems validation, change management and regulatory inspections, alongside the technical expertise and stakeholder management skills needed to drive risk-based validation approaches, maintain compliance, and support the adoption of emerging technologies within a regulated environment.

Key Responsibilities

• Preparation and approval of validation documentation or management of the process (fulfilling the Quality Assurance role) in accordance with the relevant processes (e.g. Quality Management System).
• Monitoring project and/or support activities to ensure systems are fit for purpose, that significant risks are identified and mitigated, and that the approach and rigor of validation is in proportion to the risks the systems present to regulated business processes.
• Providing and/or facilitating quality assurance oversight for the automation of business process associated with pharmaceutical manufacture and distribution.
• Project problem identification/resolution/avoidance; typically involving ongoing interaction with management teams within Tech functions, site and local operating company Quality organisations, and Third Party suppliers/service providers.
• Participating in the deployment, maintenance and inspection support of multiple global projects including responsibility, with management oversight, for the developing solutions that maintain compliance and keep validation on schedule and on budget.
• Ensuring issues/risks are identified, mitigated and/or escalated for items that could adversely impact quality compliance associated with projects/systems.
• Provision of performance measures to drive performance and continuous improvement.
• Performing periodic compliance reviews of Tech systems.

Minimum Skills and Qualifications

• Broad experience in providing validation, deployment, change management, and inspection support of large, complex, computerised systems.
• Understanding of pharmaceutical manufacturing and distribution regulations, guidelines, principles and expectations.
• Technical knowledge to support quality and validation decision making for GxP analytical, manufacturing, distribution and IT computerized systems.
• Demonstrated ability to interpret and apply company guidelines, principles and expectations such that systems are validated in proportion to the risk they present to patient safety and product quality.
• Demonstrated ability to handle multiple priorities and complete work within agreed timescales e.g. key QA role deliverables.
• Demonstrated knowledge of regulatory inspection process including specific queries of computer systems validation/compliance activities and documentation.
• Effective communicator with ability to collaborate and form strong partnerships within teams and diverse stakeholders/customers that result in "win-win" outcomes to achieve business goals and objectives.

Preferred Skills and Qualifications

Working knowledge of ‘New Technologies’ within a regulated environment:

• Robotic Process Automation
• Artificial Intelligence/Machine Learning
• Biometrics and Electronic Signatures
• Cloud (IaaS, PaaS, SaaS)
• Automated Testing Tools

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.

Inclusion at GSK

GSK is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, 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.

If you need any adjustments in the recruitment process, please get in touch with our Recruitment team (EMEA-GSKLink@allegisglobalsolutions.com) to further discuss this today.

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