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Quality Lifecycle Management Specialist - Validation
Site Name: UK - West Sussex - Worthing
Posted Date: Jan 7 2025
Closing Date for Applications: 21st January (COB)
Quality Lifecycle Management Specialist, Validation - 12 Months Fixed Term Contract
We are currently recruiting for a Lifecycle QA Specialist to join our team at GSK Worthing. The role will organise and provide expertise to the site to ensure that all Regulatory changes and Validation operations and exercises are carried out in compliance with regulatory and company requirements.
You will be required to act as a Validation subject matter expert for one or more specific areas of the GSK Worthing site.
In this role you will:
1. Provide input, track and manage the Site Validation Master Plans in conjunction with the Value Stream Validation Teams.
2. Write, review and approve validation lifecycle documentation where required and ensure they comply with relevant GMP/GDP. Validation lifecycle documentation includes Validation Plans, interim and final Validation Summary Reports.
3. Maintain up to date with industry standard expectations and ensure that both team and key customers are kept informed of changes to validation or regulatory requirements.
4. Ownership and oversight of the site Change Control process.
5. Provide CSV support for site projects.
6. Ownership & oversight of QC Lab equipment access administration.
Why you?
Qualifications & Skills:
We are looking for professionals with these required skills to achieve our goals:
1. Degree in a scientific or engineering discipline (or equivalent).
2. Good knowledge of GMP/GDP within a Pharmaceutical Environment
3. Effective communication skills and ability to communicate and influence at most levels of management
4. Ability to build networks, to secure buy-in and support for plans and ideas
5. Develops new ideas and solutions about specific issues. Proven track record of problem solving.
6. Knowledge and application of the principle of the Quality Management System.
Preferred Qualifications & Skills:
If you have the following characteristics, it would be a plus:
1. MSc or PhD in a scientific or engineering discipline
2. Awareness of how the impact of technical changes can affect the quality of the product, any impact to the overall order fulfilment process and suggest how the impact can be minimized.
3. Working knowledge of relevant Site systems, e.g. MERPS, VQD
4. Ability to plan, organize and control workloads of self to meet deadlines and deliver schedule and targets.
5. Good presentation skills. The ability to present information in a clear and concise manner in order to support project activity and audits.
About Worthing Manufacturing Site:
Manufacturing at the Worthing site is for antibiotics. It is advised that you take this into consideration when deciding to apply for this position.
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.
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. The helpline is available from 8.30am to 12.00 noon Monday to Friday, during bank holidays these times and days may vary.
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.
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.
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