Majid Siddiqui

Project Cqqa & Documentation Lead Billingham Uk @FUJIFILM Biotechnologies

GB

Fujifilm Biologics is leading global biologics CDMO. The Japanese parent company has made significant investments across all its global sites including £400m Borealis project in Teeside UK- the building of a new large biologics manufacturing facility and warehouse consisting of 5 production lines – 3 dedicated to mAb and 2 to viral therapies. The project implements the KojoX Global strategy. My role is as a senior lead in the CQV team, reporting to the project CQV director. In summary the role is to review and gatekeep project CQV documentation, templates, processes and provide guidance and support on the project where necessary to ensure compliance with regulatory and industry guidance such the MHRA and ISPE. Activities include- • “QA” oversite on the Construct & Qualify stage of the project that does not officially require QA review/approval. • CQV document reviews using Kneat. • To gate keep CQV templates and folders in Kneat in accordance with the site Process Mapping Document (PMD). • Introducing processes to ensure paper documentation is kept to a minimum and to promote the use of eDocuments. E.g. vendor FAT/SAT protocols. • Working closely with the CQV leads for Facility Unit Operations (FUO) and Process Unit Operations (PUO). • Participating in all CQV activities for PUO in the Out Of Place (OOP) Facility – vendor SATs / IQ/ OQs. • Participating / contributing to project planning meetings. • Training out new ways of working / processes on the project e.g. True copy verification. • Providing evidence to support site change controls. • Supporting the creation and maintenance of the Project Master Document register (MDR) used to provide project metrics. • To support facility commissioning activities through review of protocols and vendor TOPs. • Use of Kneat (power user), Procore, EIDA, Veeva EQMS, MasterControl, Compliancewire. • Supporting CQV activities in the OOP facility for all items of process and QC equipment.

School of Pharmacy (SOP) University of London

BPharm Hons., Pharmacy