Qualified Person (QP) Irvine, Scotland
Job description
Posted Date: May 16 2023
CLOSING DATE: 30th May 2023
- This role can be based at various GSK sites across the UK depending on the current location of the successful candidate. Specific locations can be discussed at the point of application.
GSK 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 2.3 billion packs of medicines and doses of vaccines in 2022.
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.
The Qualified Person (QP) role provides a UK batch certification and release service to the Principal Trading Companies and Trading Partners, to ensure compliance with the GMP aspects of the laws governing the importation of products into the UK.
In this role you will…
- Ensure a compliant operation is in place to allow for UK certification of imported batches of pharmaceutical products.
- QP certify batches of multiple dose forms of pharmaceutical products imported into UK.
- Ensure oversight of supply site operations via formal quality meetings with supplying sites and support regulatory inspections of supply sites, as required.
- Ensure the UK Importation operation is inspection ready and front regulatory inspections of the QP certification process.
- Maintain knowledge of legislation changes and proposals applicable to QP Certification, evaluate impact and propose mitigation for their compliant management and/or introduction.
- Ownership of specific Quality Systems.
Why you?
Qualifications & Skills:
- Science degree and experience in pharmaceutical manufacturing and quality operations.
- Certified QP with experience of QP certification of products and who has previously been named on a manufacturing licence as a QP.
- Experience with the certification of major dose forms (tablets, cream/ointments), aseptic sterile manufacture and biopharm products.
- Knowledge of Manufacturer Importation licences and Wholesaler Dealer Licences.
- Experienced in UK / EU inspections.
- Broad knowledge of quality management / GMP and GDP.
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 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 [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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