Qualified Person (QP)

Job title:

Qualified Person (QP)

Company

GlaxoSmithKline

Job description

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 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 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.Please Note: The role is a site-based role.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.CLOSING DATE for applications: Monday 14th of October 2024 (COB).Basic Qualifications:Qualified Person (QP) stated on a current UK Manufacturer’s/Importer’s licenceRelevant experienceBenefits:GSK offers a range of benefits to its employees, which include, but are not limited to:Competitive base SalaryAnnual bonus based on company performanceOpportunities to partake in on the job training coursesOpportunities to attend and partake in industry conferencesOpportunities for support for professional development/chartershipAccess to healthcare and wellbeing programmesEmployee recognition programmesHybrid (onsite/remote) working within GSK policies (post training period)If you would like to learn more about our company wide benefits and life at GSK we would suggest looking at our webpage .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 or 0808 234 4391.Please note should your enquiry not relate to adjustments, we will not be able to support you through these channels. However, we have created a UK Recruitment FAQ guide. Click the and scroll to the Careers Section where you will find answers to multiple questions we receive .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/ AgenciesGSK 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 site.

Expected salary

Location

Hertfordshire

Job date

Fri, 27 Sep 2024 01:20:13 GMT

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