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Qualified Person

2 months ago

Ware, Hertfordshire, United Kingdom GSK Full time
Tên địa điểm: UK - Hertfordshire - Ware RD, UK - Essex - Harlow
Ngày đăng tuyển: 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)..,

  • 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).

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:

  • Qualified Person (QP) - stated on a current UK Manufacturer's/Importer's licence
  • Relevant experience

Benefits:

GSK offers a range of benefits to its employees, which include, but are not limited to:

  • 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)

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.

Là một công ty được thúc đẩy bởi các giá trị của chúng tôi về sự tập trung của bệnh nhân, tính minh bạch, tôn trọng và tính toàn vẹn, chúng tôi biết sự hòa nhập và đa dạng là điều cần thiết để chúng tôi có thể thành công. Chúng tôi muốn tất cả các đồng nghiệp của mình phát triển mạnh tại GSK mang lại trải nghiệm độc đáo của họ, đảm bảo họ cảm thấy tốt và tiếp tục phát triển sự nghiệp. Là một ứng cử viên cho một vai trò, chúng tôi muốn bạn cũng cảm thấy như vậy.

Chúng tôi tin vào một nền văn hóa làm việc nhanh nhẹn cho tất cả các vai trò của chúng tôi. Nếu tính linh hoạt là quan trọng đối với bạn, chúng tôi khuyến khích bạn khám phá với nhóm tuyển dụng của chúng tôi những cơ hội là gì.

Xin vui lòng liên hệ với chúng tôi nếu bạn muốn thảo luận về bất kỳ điều chỉnh nào đối với quy trình của chúng tôi, điều này có thể giúp bạn thể hiện sức mạnh và khả năng của mình. Bạn có thể gọi cho chúng tôi theo số hoặc gửi email

Khi bạn nộp đơn, chúng tôi sẽ yêu cầu bạn chia sẻ một số thông tin cá nhân là tự nguyện. Điều này sẽ được sử dụng để giúp chúng tôi hiểu chúng tôi đang làm tốt như thế nào trước tham vọng hòa nhập và đa dạng của chúng tôi. Chúng tôi thực sự sẽ đánh giá cao nó nếu bạn có thể dành một vài phút để hoàn thành nó. Hãy yên tâm, Người quản lý tuyển dụng không có quyền truy cập vào thông tin này, nó không được sử dụng trong bất kỳ phần nào của quy trình lựa chọn và chúng tôi sẽ bảo mật thông tin của bạn và sử dụng ẩn danh.

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