- Provide Qualified Person certification (as defined in EU directive 2001/20/EC, regulation 536/2014, Article 51 of Directive 2001/83/EC and UK equivalents) and perform QP release of a range of bulk and primary packed Investigational medicinal products.
- Ensure compliant operations are in place to allow for UK certification of batches of Investigational Medicinal Products and assure products meet regulatory requirements.
- Maintain knowledge of legislation changes applicable to QP Certification (including evaluate impact and propose mitigation for compliant management and/or introduction).
- Provide QP advice to GSK project teams, external collaboration partners and sponsors concerning acquisitions and unlicensed medicines to reduce regulatory risk to GSK and ensure information and other QP assurances are obtained (as required).
- Build and maintain internal and External business relationships (communicating and interacting at various levels internally and externally). Incorporate effective processes in Product Quality Pharma R&D to provide oversight of manufacturing facilities (pilot plant and/or clinical packaging and distribution).
- Participate in audits/investigations (eg; Quality Investigations, customer complaints and vendor complaints) and recommend corrective and preventative actions (and follow up on the implementation of those recommendations).
- Qualified Person (QP) - stated on a current UK Manufacturer's/Importer's licence
- Relevant experience
- Competitive base Salary
- Annual bonus based on company performance
- Opportunities to partake in on the job training courses
- Opportunities to attend and partake in industry conferences
- Opportunities for support for professional development/chartership
- Access to healthcare and wellbeing programmes
- Employee recognition programmes
- Hybrid (onsite/remote) working within GSK policies (post training period)
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Qualified Person - Hertfordshire, United Kingdom - GSK
Description
工作地點名稱: UK - Hertfordshire - Ware RD, UK - Essex - Harlow刊登日期: May 8 2024
We have new opportunities for Qualified Persons (QPs) to join our Quality Assurance (QA) team at our Ware R&D and Harlow sites. As a QP you will perform the quality assurance activities and quality oversight of the GMP functions performed within Pharmaceutical Research & Development processes (including batch-release for manufactured product for clinical trial purposes).
Responsibilities (include)..,
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 & Harlow R&D Sites:
We have vacancies as part of team expansion at both our Ware R&D site and our Harlow site (based in Hertfordshire/Essex). Both sites are involved with the Research and Development of GSK's medicines and the manufacturing and/or packaging and certification for clinical-trial purposes.
CLOSING DATE for applications: Tuesday 28th of May 2024 (COB).
Basic Qualifications:
Benefits:
GSK offers a range of benefits to its employees, which include, but are not limited to:
If you would like to learn more about our company wide benefits and life at GSK we would suggest looking at our webpage Life at GSK | GSK.
作為一家以患者為中心,透明度,尊重和誠信的價值觀驅動的公司,我們知道包容性和多樣性對於我們成功至關重要。 我們希望我們所有的同事都能在GSK中茁壯成長,帶來他們獨特的經歷,確保他們感覺良好並不斷發展自己的事業。 作為角色的候選人,我們希望您有同樣的感受。
我們相信所有角色都具有敏捷的工作文化。 如果靈活性對您很重要,我們鼓勵您與我們的招聘團隊探討機會是什麼。
如果您想討論對我們流程的任何調整,可以幫助您展示自己的優勢和能力,請隨時與我們聯繫。 您可以致電 或發送電子郵件給我們
在您申請時,我們會要求您分享一些自願的個人信息。 這將用於幫助我們了解我們對包容性和多元化抱負的態度。 如果您能花點時間完成它,我們將非常感激。 請放心,招聘經理無法訪問這些信息,不會在選擇過程的任何部分使用,我們會以保密方式處理您的信息並匿名使用。
