Macclesfield, England, United Kingdom
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.
Moderna UK is a subsidiary of the multibillion dollar American Biotechnology firm Moderna Inc. Moderna is at the forefront of pioneering research into and development of medicines based on RNA technologies. They manufacture mRNA-based therapies for a number of diseases the most prominent of which is the Coronavirus vaccine that was made available during the 2019 pandemic. The UK site is a new manufacturing facility built from the ground up in Oxfordshire and is a collaboration Moderna and UK government. The Oxford vaccine manufacturing facility is one of the cornerstones of the UK governments future pandemic readiness strategy and for Moderna represents a “Resilience”, site crucial to its global strategy for vaccine production and availability. The site is similar Moderna vaccine facilities in Australia and Canada. I lead and manage from a QA perspective the commissioning, qualification and validation (CQV) activities for the Facility, Utilities, Equipment and Process controls systems (PCS) for the new UK factory. Reporting directly to the UK site quality head. Key activities included • Managing activities in line with project timelines and expectations • Review and approval of vendor documents. • Review and approval localised validation lifecycle documents. • Participation and collaboration at a local and global level with project stake holders. • Liaising and collaborating closely with EPCM CQV engineers to ensure EU GMP objectives for the project are met within expected project timelines. • Review of global documentation including RAs to insure there is alignment across global sites. • Escalating GMP concerns with UK site Quality team. • Overseeing from a QA perspective the CQV activities in the Out Of Place testing facility. • Assessing leveragability of testing conducted during FAT, SAT and commissioning for the purposes of qualification and validation. • Involvement in EMPQ & Integrated water runs for process validation and in preparation for PPQ batches.
Project QA / Project QE lead for all CIP systems associated to new equipment trains in DSM 4 & DSM 5 at Hillerød Denmark. All QA and Risk management activities associated with commissioning, qualification and validation of CIP systems and cycles. The project is based on the application of ASTM E2500 - Risk based approach to specification, design and verification of biopharmaceutical manufacturing facilities and equipment
New role as QAV manager now for both the Galactica and Oculus branches of Large Scale Microbiological Expansion (LSME) project. QA oversight for Project Galactica delegated to a direct report. Galactica expands Fujifilm’s existing facility to increase batch manufacturing capacity for a number of existing and new commercial products for high profile customers. Galactica is focused mainly on Facilities and Utilities expansion. Additional QAV responsibilities for project Oculus - The Technical Transfer of an commercial product encompassing the building and furnishing of a complete new Microbial Facility (MF5) to house both upstream and downstream processing capabilities for a single commercial product. Full QA responsibilities for all Validation lifecycle documents including events processing and asset release for both Upstream and Downstream Bioprocesses including: Upstream: -Media preparation vessels, Nutrient Feed Vessels, Glucose Vessels & Supply, Inoculum, preparation isolator, Shaker Incubator, Seed Fermenters, Production Fermenter, Ammonium Hydroxide supply, Mass Spectrometer, Homogeniser and Harvest vessels. Downstream:- Purification suite, Dilution & Centrate vessels, Single Use Mixing frames, Centrifuge, Tangential Flow Filtration, Buffer Preparation, Chromatography resin mixer & Media wand Chromatography Controller, Chromatography Columns, Including CIP systems where required.
QA manager on the Large Scale Microbial Expansion (LSME) Project at Fujifilm Biologics Teeside. Reporting to Project Director of QA. Responsible for QA review and approval of all QA activites associted with all Upstream GMP production and processing equipment within in the scope of the Galatica wing of the expansion project i.e. 13 systems associated with production and manufacturing, including clean utilites and 5 systems associated with Warehousing and distribution, including systems crucial to the UK and US goverments efforts against COVID 19. QA oversight of all project associated CQV activites excluding automation. Tasks include close collaboration with the princilpe EPCM validation representatives and Fujifilms automation team. Contribution to project co-ordination and planning activities. Contribution to project change control activities and deviation/event management. Management of all Galactica project quality documentation within the Fujifilm QMS.
Greenwich (GW) Pharmaceuticals is the only company to have licences to grow and produce marijuana to treat medical indications such as certain forms of epilepsy and Multiple Sclerosis. GW produce Cannabinoid based medicines such as the product Sativex® (nabiximols) the first natural cannabis plant derivatives to gain market approval in any country, and Epidiolex® for epilepsy. Reporting directly to the Director of IT Services. The role is to provide Information Technology (IT) and Information System (IS) compliance support to the clinical services group. Working closely with stake holders and approved third parties to plan and execute projects is a Key aspect of this role. Activites I get involved in can be classified as: Validation of GCP IT systems icluding Cloud based systems. • Providing validation and compliance support to PV for their PV system upgrades and maintenance activities. • Ensuring clinical computer system compliance with principles of data integrity. • Ensuring computer system compliance with 21CFRpart 11. • Updating of local and global SOPs and Risk Assessments pertaining to IT / IS. • Development of a lean and risk-based approach to SDLC requirements. • Interpretation and application of GAMP 5 guidelines. • Contributing to process improvements. • Being a core team player in IT related projects and managing project deliverables.
Lonza Netherlands is a world leading Cell & Gene Therapy specialising in the manufacture of ATMPs. Ideally located in the centre of Europe, Lonza Netherland supply's gene therapy products across Europe. Specialises in Apheresis products for both autologous and allogenic administration. The site manufactures aseptic, patient specific blood and tissue-based products, HIV based Lenti-Viral Vectors for transduction and Stem cell therapies developed from a variety of human cell types. Boasting a state-of-the-art facility with over 350 highly skilled employees the Netherlands site has become a major player in the Cell & Gene Therapy sector. Initial training undertaken: site QMS processes, manufacturing processes, An overview of the genetic manipulation techniques employed at the site and the product categories manufactured under the sites Manufacturing and GMO licenses. The procurement process for starting materials under the sites Tissue Establishment license. Project work: Focusing on FDA PAI readiness, from a QA Operations perspective, for a number of clinical projects for which the BLA was in progress. Tasks under taken: • Detailed planning with full granularity of QA Operations requirements and items to be verified for PAI • Conversion of the PAI requirements into detailed spreadsheets with full traceability to aid requirements tracking. • Regular reporting of QA operations PAI readiness progress to the PAI project manager. • Delegating spreadsheet completion tasks to appropriate Lonza Departments • Organising and hosting QA Operations PAI readiness update meetings with stake holders • Supporting QA Systems to close out Deviations, CAPAs and Change Controls for projects subject to PAI. • Regular contact with clean room staff as part of QA oversight of existing and improved processes relating to PAI projects. Systems routinely used: Trackwise to document Non-conformances, CAPAs and changes, DMS Documentum to author and review documents.