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.
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 offers a hybrid working model, empowering you to find the optimal balance between remote and in-office work.
Discover more about our company wide benefits and life at GSK on our webpage Life at GSK | GSK
GSK are currently recruiting for a QA and Validation Officer on a 12-month fixed term contract/secondment for their Barnard Castle Site. Start available January 2024.
The role of QA NPI & Validation Officer is to lead and organise Validation activities in order to provide an effective validation service and to ensure that all operations, changes and projects relating to processes, facilities, equipment and CSV/IT Validation are assessed and validated in line with regulatory and company requirements.
In this role you will…
* Plan validation activities to ensure customer and business needs are met in alignment with the overall project plans and objectives; accountable for validation maintenance for Processes, Facilities, Equipment, CSV and IT projects.
* Prepare and issue Validation Master Plans, Summary Reports and other required documentation for a validation exercise.
* Participate in the Stream Validation Working Party to promote and maintain effective working relationships with Business Unit
* Present & justify validation scope and documents to both internal and external auditors.
* Interface with staff in other departments to coordinate resources and complete validation activities in a timely manner.
* Work with the business to promote the value of validation activity in all lifecycle stages of projects and supporting the GPS.
* Coordinate the completion of change control activity associated with Validation activities
Why you?
Basic Qualifications & Skills:
We are looking for professionals with these required skills to achieve our goals:
* Graduate level qualification in a relevant degree and/or a demonstrated track record in the pharmaceutical industry
Preferred Qualifications & Skills:
Please note the following skills are not necessary, just preferred, if you do not have them, please still apply:
* Good knowledge of GxP within a Pharmaceutical Environment
* Knowledge of at least one of the following:
o System Qualification
o Process Validation (including continuous verification)
o CSV/ IT Validation
o Cleaning Validation
* Knowledge of the Change Control process – MCs and ECCs
* 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
Closing Date for Applications: 19th December 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.
We are addressing gender equality at all levels within our organisation, we also remain committed to improving ethnic diversity within GSK and recruiting and developing talent that mirrors the communities in which we work. With support from our Global Disability Council and our employee resource group, the Disability Confidence Network, we are working hard to create an inclusive workplace.
We want GSK to be somewhere everyone can feel a sense of belonging and thrive. Our success absolutely depends on our people.
ZSC Divestment
The ZSC Brand was divested to an external company in October 2021. The supply chain continues to operate within GSK as a contract manufacturer supplying oral solid dose antibiotics. Once the manufacturing supply agreement has come to an end, and in the absence of any other alternative options, GSK would be proposing to close the ZSC sites. GSK would explore all options for retraining, supporting employees who might be at the risk of redundancy.
During the expected 3-5 years duration, commencing October 2021, 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. You will also be able to utilise the ZSC Retraining and Development programme to identify and fund upskilling towards your future career ambition. In addition to this, there is an employee retention scheme which offers further financial bonuses for working within the business.
Why Us?
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 organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.
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 Ukdiversity.recruitment@gsk.com 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.
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 GSK’s Transparency Reporting For the Record site.