Lee Baker

KEY SKILLS Strong IT/QA background Good communication, analytical and reporting skills Ability to be a team player, whilst retaining independence from a Quality perspective Experienced in managing Global Teams Clear understanding of GxP (GMP, GLP etc) standards as defined in the ICH Guidelines, EC Directives, FDA regulations and local laws Ability to hold technical conversations with IT specialists Experience of IT Quality and computer validation (CSV) within Pharma industry Experience of authoring, reviewing and approving Quality documentation (Polices/SOPs/Validation protocols/reports) Experience of ISPE GAMP Good Practice Guide on IT infrastructure control and Compliance and Network qualification Good working knowledge of FDA, EU GMP and ICH regulations, GLP and GMP (GxP) Experience of change management (ICH guideline Q10) Experience of being involved in audits and facing regulatory inspections Detailed knowledge of 21 CFR part 11 and experience of implementing it Knowledge of CSV validation strategies and life cycles and GAMP guidelines Review and approval of SAP Change Controls to ensure process compliance Compliance to GMP & SOX requirements