Qualified Person (QP) Ware, England
Job description
Posted Date: Mar 24 2023
The Quality function promotes quality and compliance through the product life-cycle in the manufacturing and production operations across GSK Sites. The team supervises all quality related systems, improvement procedures and documentation (including analytical data and information) to ensure products released have been manufactured and packaged according to all Regulatory and cGMP requirements (including appropriate certification for the UK/EU markets).
Job Purpose:
A Qualified Person (QP) reviews and certifies finished products (batches) for release/onward progression (to market). QPs are responsible for ensuring that individual batches are manufactured in compliance with laws (for all the Member State where certification takes place) and in accordance with the requirements of marketing authorization (MA). All released products must conform to required quality standards (by reviewing appropriate documentation) and have been manufactured and packaged according to the regulatory dossier, Good Manufacturing Practice (GMP) and business requirements.
In delivering the role, the QP takes informed decisions on the suitability of products to be released. This includes completing SAP activities (to allow release of batches for further processing or shipment) and ensuring deviations from GMP (or company standards) in manufacturing/packing operations are fully recorded and investigated. This element of the role extends to appropriate steps/measures (CAPA) being assigned and any risk to product being fully assessed. You will also provide oversight of change-control, complaint, distribution, self-inspection and other key processes within site’s Quality Management Systems (QMS). Throughout your day-to-day work you will promote quality and compliance, including monitoring of improvement activities.
The role has a strong focus on raising collective performance and continuous quality improvement. As a member of the quality assurance team, you will promote team working and effective communication across GSK’s wider Quality functions (across multiple sites). You will also deputise for the Quality Managers in completion of QA approval of key site documents (eg; deviations, Standard Operating Procedures (SOPs), technical reports, etc).
About You:
You will be a Qualified Person (QP) – this is key to delivery in this role. Your QP qualification must be recognized in the UK.
As this role is multi-faceted and collaborates with a wide variety of on-site production and operations teams, you will also be self-motivated with strong experience of working in quality at a sophisticated manufacturing site. You will be resilient and calm, with strong communication skills.
About Ware Manufacturing Site:
Medicines at Ware are presented as either Respiratory devices or in Oral Solid Dose form. The site holds a unique position in our network as the only site responsible for launching the company’s pipeline of new medicines in these dose forms, many of which are life saving medicines.
CLOSING DATE for applications: Friday 31st of March 2023 (COB).
When applying, please include your CV and describe how you meet the proficiencies for this role.
Basic Qualifications:
Qualified Person (QP) stated on a current UK Manufacturer’s/Importer’s licence
Relevant experience
About GSK:
GSK has changed. In July 2022, we demerged our world-leading consumer healthcare business, Haleon. We are now a fully focused biopharma company. We prioritise innovation in vaccines and specialty medicines, maximising the increasing opportunities to prevent and treat disease. At the heart of this is our R&D focus on the science of the immune system, human genetics and advanced technologies, and our world-leading capabilities in vaccines and medicines development. For more information on GSK please refer to our website: www.gsk.com
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
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