Quality Validation and CSV Senior Specialist

About this role

Responsibilities

• This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
• Plan, lead and execute validation activities for processes, facilities, equipment and simple computerised systems.
• Provide quality oversight for new product introduction, technical transfers and batch documentation.
• Prepare and maintain validation protocols, test scripts, final reports and supporting evidence.
• Make timely, documented, risk-based quality decisions and clearly communicate rationale to stakeholders.
• Support internal and external inspections, prepare evidence and close agreed actions.
• Drive improvements to validation processes, templates and tools to increase efficiency and compliance.
• Why You?
• Basic Qualification
• We are seeking professionals with the following required skills and qualifications to help us achieve our goals:
• Degree in a scientific, technical or engineering discipline, or equivalent relevant experience.
• Practical experience in validation or quality assurance in a regulated environment.
• Experience in computerised system validation or lifecycle activities for IT/automation systems.
• Working knowledge of good manufacturing practice (GMP) and quality management systems.
• Experience producing and reviewing validation and batch release documentation.
• Clear communication skills and ability to work effectively with cross-functional teams.
• Preferred Qualification
• If you have the following characteristics, it would be a plus:
• Advanced degree in science, engineering or a related technical field.
• Experience applying GAMP principles and data integrity requirements.
• Proven experience supporting regulatory inspections and interactions.
• Track record delivering validation for MES, automation or laboratory systems.
• Strong risk assessment skills and experience documenting risk-based decisions.
• Experience driving continuous improvement and validation tooling.
• Working pattern
• This role is a full time onsite role at Barnard Castle in the United Kingdom. On-site presence will be required for inspections, validations and technical transfer activities.
• What we value
• We look for people who are curious, collaborative and accountable. We welcome different perspectives and aim to create an environment where everyone belongs. You will be supported to develop your skills and grow your career while helping deliver high quality products to patients.
• How to apply
• If this role feels like the right step for you, please apply and tell us how your skills and experience match the responsibilities. We welcome applications from people at different stages of their career and from all backgrounds. We look forward to hearing from you.

Requirements

• Data Integrity, Detail-Oriented, Digital Fluency, GxP Regulations, Influencing Without Authority, Lean Management, Problem Solving, Project Management, Quality Assurance (QA), Risk Awareness, Technical Writing, Validation Processes
• Why GSK?
• Uniting science, technology and talent to get ahead of disease together.
• GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.
• People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.
• 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.
• Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us at
• UKRecruitment.Adjustments@gsk.com
• where you can also request a call.
• 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  Recruitment FAQ guide. Click the
• link
• where you will find answers to multiple questions we receive
• Important notice to Employment businesses/ Agencies
• GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.
• 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/