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An experienced Business Systems/Process Analyst with circa 30 years commercial I.T. experience – much of that spent in consultancy and mangement roles and within GxP and e-business environments. Quick to understand new business models and processes and excellent at fostering innovation. Adept at bridging between business and technology stakeholders with excellent communication skills, from requirements elaboration to process models to presentations.Experience Summary• Extensive BA and hybrid BA/PM: processes/procedures, requirements, architecture, business/technology - GxP/GAMP and non-GxP across many industry sectors.• International working on sites in Switzerland, US, Germany, Belgium, Japan and remotely managing projects in US, China, Japan, Singapore, South Korea.• Web and mobile solutions/projects (serialised product verification, knowledge management, H&S, eLearning, vehicle tracking) with good understanding of full web/mobile technology stack.• Pharma validation / CSV / GxP / GAMP / Serialisation / Consultancy.• GxP IT Infrastructure Qualification.• SOx compliance remediation, SOPs, audit.• Consultancy and project management in Telco (web portal, call-data processing, organsational change).• Project, program, team/department management: - Practice manager, boutique IT consultancy - software development projects, infrastructure projects - IT Operations & Network manager across three hospitals - large IT dept. in leading NHS Heart/Lung Specialist centres across London during 90's (9 years in total).
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Corporate It Strategy LeadPorton Biopharma Ltd Apr 2019 - Apr 2022UkDeveloped a fresh corporate IT strategy for this rapidly evolving and dynamic biopharma, culminating in a fully fledged ICT operation. Out of a 3 year programme of consultation and collaboration with the business and partners, a gold-standard core infrastructure and support team/operation has come to fruition.Security, availability, performance and GxP compliance baked-in at every level - supported by an ICT-focused QMS and workflow automation. -
Csv SpecialistPorton Biopharma Ltd Dec 2018 - Apr 2019UkeQMS upgrade and biopharma production systems validation. -
Csv ConsultantPatheon Biologics B.V. May 2018 - Dec 2018Groningen, NetherlandsProviding broad based CSV consultancy to this fast paced biopharma subsidiary of Thermo Fisher Scientific. Sole CSV consultant on site - helping to mature the CSV lifecycle and validating a range of integrated analysis and control systems plus migration of legacy asset management data to corporate Maximo as part of a global rollout. -
Gxp Business AnalystBritish American Tobacco Aug 2016 - May 2018Southampton, United KingdomProcess analysis and redesign to develop global TOM for Next Gen Products, Product Stewardship function. Lead Business Analyst supporting development of processes and solution architecture for EC regulatory reporting of e-cigarette data. Full SDLC, GAMP L5, business continuity, risk analysis and transition to BAU. -
Csv ConsultantAmaris Mar 2016 - Aug 2016Belgium, Switzerland, GermanyAs contract Amaris Consultant, providing CSV and change management support to Trackwise Global Business Owner within a major pharma. Following large scale acquisition and transfer of ownership: CSV of Trackwise data separation/cleansing, system/service migration (between global pharmas) and integration with legacy SAP. -
Csv, Itiq & Sox SpecialistFisher Clinical Services Jan 2015 - Mar 2016Horsham, West Sussex, UkFocused on IT Infrastructure Qualification (ITIQ) within the BioPharma Services Division (BSD). Responsibility for shaping an ITIQ framework/methodology for BSD's global infrastructure - one that is robust, maintains compliance yet adds value to day-to-day network operations.Developing templates, SOPs and expediting change requests. Bringing ITIQ on to the critical path of major infrastructure projects such as the commissioning of new logistics centres in China and Singapore. Responsible for project managing the design and roll-out of IT infrastructure for new facilities in Singapore and South Korea.Performed a complete overhaul of SOx controls and procedures with remedial actions to bring the UK organisation into sustainable compliance for 2015 and beyond. -
Business Analyst (Csv)Synthes Jul 2014 - Dec 2014SwitzerlandPart of international team performing intensive remedial CSV activities across a range of operational systems following acquisition of Synthes (a specialist medical devices company) by Johnson & Johnson/DePuy. Based at the European HQ in Switzerland, with a dedicated project portfolio, this role required 'floor-to-ceiling' analysis of business processes and technical architectures for a range of back-office solutions. Full lifecycle responsibilities: URS, TDS, FMEA, STS, UAT, TM, ... consult/analyse/write/execute/mentor.Within a challenging corporate/local political environment, required sensitive, multi-site/culture stakeholder management, business process analysis and technical system analysis within a programme of intensive and urgent (retrospective) CSV qualification. -
Co-Founder And Operations DirectorPortalis Ltd Jan 2012 - Jul 2014Ireland, Uk, GermanyPrimary focus: Technical serialisation oriented consultancy and managed resources for big Pharma - both direct and through industry leading equipment suppliers and innovators such as Uhlmann. Packaging line upgrades, serialisation retro-fits, day-to-day support and managed services. Additionally, delivering dynamic mobile and portal technologies - e.g., mobile serialised product verification prototypes, covert anti-counterfeit measures, knowledge capture tools.
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Lead Validation AnalystAstellas Pharma Jun 2012 - Sep 2013IrelandThis is a world-class API blending and capsule filling/packaging plant using the most advanced packaging technologies.Role included business and process change projects in the areas of:- Introduction of Serialisation technology (material and process change & validation)- Anti-counterfeit technologies (PM & validation of covert technologies)- Process improvement (product handling and movement technologies)- Software requirements and solution development (BA: document tracking, back-up tracking, H&S audit)Writing, reviewing and executing validation protocols across full GxP lifecycle: IQ/OQ/PQ/PV
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It/Ba ConsultantFreelance Consultant Jun 2006 - Jun 2012Ireland, Uk, EuropeAs a freelance IT consultant and business process analyst, I worked extensively across UK, Ireland and mainland Europe on a wide variety of large and small projects. These included, for example:In the Health Foods industry--------------------------------------BA and Project Manager – SAP Business-1 ERP suite. Managing requirements, Infrastructure expansion, supplier selection and liaison between Stakeholders and main suppliers.Environmental Awareness (carbon emissions)-------------------------------------------------------------Between a UK university and project sponsors in Okinawa (Japan) and Japanese Ministry of Environment. Delivered multilingual web portal addressing climate change, CO2 monitoring and information dissemination to centres in Japan. Design, liaison and delivery management with international development team. Some time in Tokyo and Okinawa, Japan.Parallel Computing--------------------------Pre-sales support for US “Application Grid” technology vendor to the Finance Sector across UK Finance sector (making high-performance linear code 'parallel' without a rewrite) . Feasibility studies, relationship management, requirements capture.
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Freelance ConsultantSun Microsystems Jun 2003 - Jun 2006London, United KingdomSenior Business Analyst across a wide range of ebusiness-related projects including, for example:- eLearning portal project known as “eUniversities”: Requirements capture, solution specification, quality management systems and project management.- On-line call data/profile management tools for leading telco: requirements elicitation, solution design, software team management and delivery responsibilities. -
Associate PartnerCompany-I 1997 - 2003London, United KingdomBoth as freelance consultant (Oracle DBA, development and e-business consultancy) and an Associate Partner responsible for the eBusiness consulting practice. Engaged on multiple projects as a lead consultant, project manager and hands-on techy (infrastructure, DBA, web development and back-end integration). Worked across multiple sectors including Pharma, Telco, Finance and Energy. Presentations and documentation for all types of audiences - pre and post-sales support. Managed teams and projects across Europe and East Coast US, typically within an eBusiness context. -
Customer Support EngineerHewlett-Packard Oct 1995 - Apr 1996Bracknell, Berks. UkProviding second-line support to corporate clients using HP-UX. Specialised in raw-volume storage set-up and support. -
Unix And Db Support Analyst (Contract)Gsk Jul 1995 - Oct 1995West London, UkHands-on UNIX sys admin and Oracle & Sybase DBA. -
Operations And Network ManagerUk National Health Service Aug 1986 - Aug 1995Managing multi-hospital I.T. services team within world-renowned Special Health Authority, Post Grad ctr for Cardio-Thoracic surgery, medical research and training/education.Responsible for one of first NHS campus broadband roll-outs, early adoption of standardised patient record systems, care-critical I.T. infrastructure and support services across sites throughout London, UK.In this organisation I established the core of my technical IT and management abilities, cutting teeth on UNIX and Oracle and gaining immense experience across project lifecycles, major business change, team leadership and interpersonal communication. Through my nine years at the NHS I progressed from operator to 'Operations and Communications Manager' across three hospitals considered world-class in Heart & Lung post-grad training and specialist healthcare.
Russell Cunningham Skills
Frequently Asked Questions about Russell Cunningham
What is Russell Cunningham's role at the current company?
Russell Cunningham's current role is GxP IT Mgr / Business Analyst / PM / CSV Specialist.
What is Russell Cunningham's email address?
Russell Cunningham's email address is ru****@****ail.com
What skills is Russell Cunningham known for?
Russell Cunningham has skills like Consulting, Project Management, Management, Professional Services, Solution Architecture, Change Management, It Strategy, Business Analysis, Leadership, Outsourcing, Mobile Devices, Infrastructure.
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Russell Cunningham
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Russell Cunningham
Binding Store Ltd- Worldwide Suppliers Of New,Used And Refurbished Bindery And Print Finishing EquipmentWelwyn Garden City2bindingstore.co.uk, bindingstore.co.uk -
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Russell Cunningham
England, United Kingdom
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