Wayne Hunt Email & Phone Number

London Area, United Kingdom

Delivering direction, guidance and support in the regulated, Pharma environment, covering all aspects of Quality and Compliance.

Pfizer Sandwich

• Project Manage the Global Operations IT Sandwich site exit. Planning disposition of 228 systems with data harvesting and asset divestature. Full change control and CMDB update. Documentation and resource management.
• Technical Project Mange System transitions new site owner, planning, documentation (108 utility and site based Systems). Inclusive CMDB retirements and end-of-life process execution
• Data Centre Decommisioning (UK Sandwich Site PM) and data/system transition to European Data Centre. Service process modification, CHP and SLA modification and all associated change control processing.
• Project Manage the implementation/upgrade and re-validation of Electronic Document Management System as part of the Continual Service Improvement Cycle (ITIL).
• Migration and implementation of multiple systems to within Global Operations at Sandwich. (CAD, AS400, EDMS). All SDLC based implemtations and fully controlled under Service Transition phase of ITIL.
• Configuration, testing and implementation of multiple 64bit architecture CAD and SQL environments.

Sandwich

• Technical Project lead on the Asset Verification project as part of the business process change to an ITIL based configuration and change management.
• Business Modelling using ControlES and transition of services to the Continuous Improvement Cycle.
• Administration of the Maintenance, Repair and Operation (MRO) application hosted on the AS400 for Engineering Services, including the migration of the AS400 from the UK to the USA data centre. Data Analysis (Cognos.
• Project manage the design and installation of a validated Electronic Document Management System (Meridian EDMS), inclusive of concept, risk analysis, purchase, vendor contract and audit, implementation, training, full.
• Creation and execution of the qualification packages for the validated MAPS User Log system. Cognos Impromptu version 7.3 reporting system 2nd line support. LIMS Administration (Applied BioScience SQL *LIMS)Waters.
• Technical Project Manager on Site Closure, dispostion of systems and associated documetation, data harvesting and system transition to new business owner. Part of the 'Lights Out' team.

Sandwich

• Global Technical lead for implementation, configuration and documentation of two validated pharmaceutical projects. The Water Millennium32 CDS and the SSI CyberLab Laboratory data archive. This is entailed the creation.
• Originally employed to build and run a Laboratory Support Team to work with validated systems ensuring compliance with the 21 CFR 11 (FDA Code of Regulations) Maintenance and update/upgrade of Laboratory based systems.