- 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 - Ware, United Kingdom - GSK
Description
Tên địa điểm: UK - Hertfordshire - Ware RD, UK - Essex - HarlowNgày 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)..,
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.
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