We make and supply medicines and vaccines all around the globe and our teams own every production stage, from creating quality products at our manufacturing sites to designing effective supply forecasting and regulatory inspections; all powered by digital, data and analytics. We operate at impressive scale, producing over 1.7 billion packs of medicine and 767 million vaccine doses in 2021.

We continue to modernise, so we can launch even more new products at speed whilst turbo-charging delivery across our entire portfolio through our relentless focus on quality, safety, and service. The way we work will change. For some, the shift in technology and products will be revolutionary. Our R&D pipeline demands a new kind of supply chain, and we need the very best minds and capability to help us on our journey to make more complex products, harnessing the power of automation and robotics so we can work smarter together.

Validation QA Officer

Are you a Quality Assurance Professional seeking an opportunity to leverage and/or build upon your expertise in validation (inclusive of equipment, utilities, facilities, computer systems) working with internal and external business partners for R&D?

Do you enjoy a varied day dealing with challenges and answering the call for advice on different scenarios? If yes, the Validation QA Officer role in Small Molecule Quality Assurance (SMQA) may be the right opportunity for you to explore.

This is a great opportunity where you will deal with various situations, which you will need to provide solutions, so good problem solving skills are a must. Within QA you will be presented with issues and business proposals which you will be asked your advice to ensure quality and the patient is not affected while allowing us to grow and develop as a competitive business. You will work cross functionally with different teams, gaining experience of providing key project management direction, pilot plant systems, analytical systems, medical devices, utilities and facilities.

This role can either be based at Ware R&D or the Stevenage site.

Job Purpose

As a Validation QA Officer role in Small Molecule Quality Assurance (SMQA), Infrastructure and Validation team, you will perform the quality assurance activities and quality oversight of the Validation and GMP facilities management activities performed within Pharma R&D across the sites globally.

In this role you will be key in the following areas…

• Providing review and approval of validation lifecycle documents from a variety of QMS within the company. Provide meaningful comments to ensure compliance with regulatory expectations/requirements.
• Provide quality oversight of internal business groups and external services partners inclusive of the following quality processes
• Change control
• Deviation investigation
• CAPA
• Audit Support (when requested)
• Vendor Complaints
• Quality Alerts
• Support internal and external audits/assessments (when requested).
• May lead a project, quality program or team activities.
• Identify business, compliance or reputational risks associated with job responsibilities and communicate these upward along with suggestions for risk management solutions.
• Provide advice and consultancy to GSK project teams, internal business groups and external partners to reduce regulatory risk to GSK.
• May represent QA group as a primary business contact for specific areas.
• Build and maintain effective business relationships within internal business units and service partners.

Closing Date for Applications: Wednesday 15th March 2023

Please take a copy of the Job Description, as this will not be available post closure of the advert.

When applying for this role, please use the ‘cover letter’ of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application.

During the course of your application you will be requested to complete voluntary information which will be used in monitoring the effectiveness of our equality and diversity policies. Your information will be treated as confidential and will not be used in any part of the selection process. If you require a reasonable adjustment to the application / selection process to enable you to demonstrate your ability to perform the job requirements, please contact 0808 234 4391. This will help us to understand any modifications we may need to make to support you throughout our selection process.

• LI-GSK

Why you?

Essential Qualifications & Skills:

We are looking for professionals with these required skills to achieve our goals:

• Bachelor’s degree in a science, engineering, or life sciences from an accredited university.
• Some level of Validation experience in biopharma/pharmaceutical industry.
• Good critical thinking and problem solving mindset.

Preferred Qualifications & Skills:

If you have the following characteristics, it would be a plus:

• Proven working experience in biopharma/pharmaceutical Industry related to Quality Assurance Job scope.
• Ability to manage workload prioritisation in a fast paced changing environment.
• Excellent organisational skills
• Strong interpersonal skills.
• Strong written and verbal communication skills.
• A good team player and able to work independently.
• Experience with key Quality activities (i.e. Deviations, Customer complaints and Change Controls)

Why GSK?

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. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.

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.

Find out more:

Annual Report 2021

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. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.

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 workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.

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.

Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on [email protected] or 0808 234 4391. Please note should your enquiry not relate to adjustments, we will not be able to support you through these channels

As you apply, we will ask you to share some personal information which is entirely voluntary. We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions. We would really appreciate it if you could take a few moments to complete it. Rest assured, Hiring Managers do not have access to this information and we will treat your information confidentially.

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