Owner And Principal Consultant
CurrentOffering IT/Quality consultancy/contract services. Expertise in:IT Project/Program Management (Prince II)IT Compliance (Quality Systems, Validation, Operational Mgt)(CISA, FDA, MHRA)IT Service Delivery (ITIL/Cobit 4.0)IT Quality Training/MentoringInspection readiness auditing/remediationClients: SyngentaSymbiosis Pharmaceutical Services Wipro Technologies AstraZeneca – client accountQuality, Compliance and Validation Lead Provided ‘hands on’ compliance and validation activities for large multi-region End User Computing transition program. Developed Quality Plan (including schedules) based upon client schedules Produced IT QMS Gap Assessment and traceability to client QMS Produced Quality and Compliance work product log Developed and implemented IT Service Support procedures Developed Qualification and Validation approach for client tools Provided Quality oversight/review of service transition activities (including to off-shore resources)IT Quality Consultant Performed IT QMS gap assessment Developed IT QMS roadmap Developed Computer System Validation Approach and schedule Performed supplier audit