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NHS Blood and Transplant is seeking to appoint a suitably qualified and experienced supplier to provide Qualified Person services in support of its portfolio of Investigational Medicinal Product manufacturing projects. The proposed service may include: reviewing and providing regulatory and quality input into selected regulatory submissions; advising on applicable regulatory, Good Manufacturing Practice and quality-compliance requirements for biological and Advanced Therapy Medicinal Product manufacturing projects; providing regulatory, GMP and quality input into the design and development of selected manufacturing processes and facilities; reviewing assigned batches and, where all applicable legal, regulatory, GMP, Clinical Trial Authorisation, Product Specification File and NHSBT quality-system requirements have been met, certifying batches for use in approved clinical trials; mentoring selected NHSBT staff undertaking the process of obtaining Qualified Person registration; and providing associated professional, regulatory and quality advice as required. Each Qualified Person proposed by the supplier will be expected to hold and maintain the qualifications, professional eligibili
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