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.•Project Manage the business case, ROI, development, risk analysis (GMP, GLP, GCP), documentation, implementation and re-validation of a full Blue Cielo Meridian documentation system upgrade. Inclusive of budget control, vendor contract management, support and training.

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 Reporting) and workflow processing (ControlES)•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 validation documentation, upgrades and ongoing support. Project manage and technically lead the upgrade and installation of all software used in the Drawing Office and Technical records area, inclusive of AutoCAD, Architectural Desktop, and the Bentley Suite, (P&ID, 3D modelling and Piping). •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 Empower Administration and Support of all Quality Operation Laboratory Systems.Support of all systems installed in accordance with cGMP guidelines.•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 of compliant documentation, inclusive of all SOP’s and qualification scripts, user/support training. •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 across multiple platforms (XP, 2000, NT, Win9x), using a full Change Control Procedures. Management of multiple local projects, (CFR remediation, AV, SMS2, Web Cams, 2000 Active Directory, Active tagging systems), inclusive of full documentation and user training. Liaison with, and presentation to, all levels of management. Interfacing and communication directly with the scientific community to resolve technical computer issues and offer a full support service within predefined SLA’s.