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| Job Location | London |
| Education | Not Mentioned |
| Salary | Salary negotiable |
| Industry | Not Mentioned |
| Functional Area | Not Mentioned |
| Job Type | Permanent, full-time |
Provide QA oversight and support the implementation, development and management of compliance related electronic systems in accordance with EU/Annex 11, GAMP and FDA/21 CFR part 11 and Data Integrity GxP requirements (specifically GCP, GLP and GMP).Perform general administration and maintenance activities required to support implemented systems.Support Computer System Validation activities for GxP systems.Client DetailsClient is a clinical-stage gene therapy company focused on developing potentially curative treatments for patients living with serious diseases. With headquarters in New York and London, their global footprint provides them the opportunity to partner with leading institutions around the world, allowing them to deepen their understanding of diseases and their progression.Each day we work to improve the lives of patients through cutting-edge science designed to treat their specific disease. We believe each patient deserves the best treatment possible and with our highly flexible gene therapy platform and manufacturing process, we believe we can deliver on that promise.Our core capabilities in viral vector design and optimisation and gene therapy manufacturing give us a differentiated approach to developing gene therapies. Additionally, we are developing proprietary technology to potentially enable innovative gene therapy treatments whose expression can be turned on and off with an easily administered small molecule. We believe temporal control of gene therapy products has the potential to transform the gene therapy landscape.Our state-of-the-art manufacturing facility, completed in early 2018, was designed to meet global regulatory requirements, including the current good manufacturing practices (cGMP) required by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK and the U.S. Food and Drug Administration (FDA). The 29,000-square foot facility has the flexibility and capacity to produce sufficient product for all our clinical trials and will scale to commercial capacity.Description Major Activities
Keyskills :
Quality Assurance Computer System Validation CSV GxP EU/Annex 11 GAMP and FDA/21 CFR part 11