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Site Name: UK - West Sussex - Worthing
Posted Date: Jan 8 2025
Project Quality Lead - 2 Years Fixed Term Contract
Closing Date for Applications - 22nd January (COB)
This is a site-based role in Worthing, UK.
At our GSC Worthing site, we have a proud heritage in global manufacture of oral antibiotics. The site also manufactures bulk export material for use at other manufacturing sites in our network.
As a project aligned quality lead, you will be accountable for providing a quality perspective on project activities whilst acting as a decision maker on key project related quality decisions.
This role is a great opportunity to be instrumental in delivering GSK Worthing's site strategic objectives. As this role is multi-faceted and includes liaising with a wide variety of stakeholders (including on-site operations teams and senior managers), you must be a highly motivated person who has strong experience of working in complex technical and/or manufacturing situations. You will be resilient and calm under pressure, with a proven ability to influence people to achieve and drive performance. You will have a strong continuous improvement mindset and be hands-on in your approach.
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.
In this role you will:
1. Act as first point of contact for all project quality related questions, ensuring that key decisions and project progress are fed into the relevant QA forums to ensure knowledge share and project handover to business as usual is considered.
2. Understand the GSK QMS and its application to the project activities ensuring that it is considered and followed.
3. Support and approve the up-date to production area documents and associated quality documents where required including but not limited to; training materials, SOPs, SWIs, logbooks, proforma and batch packaging records.
4. Assessment of operational feasibility of new/proposed primary, secondary, tertiary and ancillary packaging materials by supporting the running of various packaging trials on shop-floor in consultation with value stream.
5. Involved in the development of key project validation documents including machine and material validation documents including but not limited to URS, QRA, IQ/OQ and PQ ensuring that GSK quality standards are built in and acting as a quality validation signatory.
6. Support training activities of Production personnel for items such as GMP or other Quality related site mandated training as well as providing mentoring and coaching of production operators, supervisors, engineering craftsmen together with technical colleagues in all relevant aspects of GMP.
Why you?
Qualifications & Skills:
We are looking for professionals with these required skills to achieve our goals:
1. Degree level qualification (or strong equivalent experience) in an appropriate discipline
2. Thorough knowledge of GMP and Regulatory requirements
3. Ability to communicate and influence effectively at all levels of the organisation.
Preferred Qualifications & Skills:
If you have the following characteristics, it would be a plus:
1. Detailed experience of Quality by Design and risk management approaches, including FMEA, RCA and technical risks assessments
2. Excellent organisational skills with demonstrated Project Management skills and experience, particularly on major technical and/or capital projects.
3. Thorough operational knowledge of manufacturing unit operations
4. Proven capabilities in enabling and driving change, delivering solutions, developing people, and building relationships across multiple interfaces and in a matrix environment.
Manufacturing at the Worthing site is for antibiotics. It is advised that you take this into consideration when deciding to apply for this position. We cannot accept applications from individuals that have an allergy to penicillin due to Health and Safety.
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. 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.
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