University Hospitals Coventry and Warwickshire NHS Trust
patients, healthcare professionals and other agencies relating to pharmaceutical aspects of clinical trials. To understand EU and UK Clinical Trial legislation relating to GCP, GMP and medicines management and ensure incorporation into the implementation of new clinical trials. To deliver specialist education and training in Clinical Trials to other healthcare more »
of the highest standard. Main duties of the job To be responsible for supporting the delivery of the PMU Clinical Trials service within the GMP and GCP legislative framework. To provide expert input into all aspects of the Clinical Trial process from liaising with Sponsors, set up and manufacture of … of Clinical Trial medicines to ensure a safe and efficient service. To ensure that all IMP activities undertaken within the Production Unit comply with GMP/GDP/GCP, Health and Safety and COSHH legislation and that all work documentation and procedure manuals meet these regulations. To support senior staff … in the tasks they undertake. Clinical trials To lead on the set-up and implementation of Clinical Trials requiring preparation or manufacture to ensure GMP, GCP, full protocol, CTA, and IMPD compliance. To generate quality technical agreements, commercial and supply agreements in response to acceptance of a clinical trial, liaising more »
within the Centre for Cell, Gene & Tissue Therapeutics. The post holder will be responsible for establishing a process development team that will support a GMP-compliant lentiviral manufacturing process. They will design and implement novel intermediate scale lentiviral manufacturing techniques in suspension cell bioreactors. The post holder will also develop … new downstream purificiation and packaging systems for the delivery of GMP-compliant lentiviral vectors to the cell manufacturing teams in the CCGTT. The post requires exceptional attention to detail and the ability to work in a systematic manner whilst keeping detailed records and managing junior staff. Main duties of the more »
any trends •Support Technical department and site with document creation and review which may include records, procedures, and communication boards •Complete audits on bakery GMP standards & Technical compliance such as G&HP, CCP, Process controls, Mobile phone audits, paperwork completion etc •Lead for Site Traceability exercise •Promote and maintain high … standards of food safety culture, promote and challenge site GMP standards including Technical, Food Safety, Quality, Compliance and Business values.. •To verify accuracy of handheld temperature probes, temperature-controlled storage equipment Qualifications&Requirements - Quality Systems & Compliance Assistant •Good IT skills with knowledge of Microsoft Office •Level 3 Food Safety •Internal more »
