Meine Dienstleistungen:
Berufliche Erfahrung:
My assets
• Presenter, speaker, (SAS Stockholm; Allan Lloyd Amsterdam; DIA data Madrid, DIA Barcelona, ERES Roche)
• Vendor Audits and Quality Reviews
• Concepts for quality management system, CAPA system, Change management, ISO9001:2015
• Process management (Policies, SOP’s, SA entries, System Validation); Risk assessment and management; CAPA plans; create, review and approval); Equipment (inventories, qualification, validation); Documentation, Templates; Training (GxP, CSV, CAPA, Company rules, Project management methodology)
• Variety of work, IT projects, lab projects (pathology, CPU, MML, Cll8, DNA, RNA), clinical trials (end point adjudication, CLL8, CLL2, Mabthera, Avastin, MAIN Avastin), Web site, CRO’s, CPU’s, from overall validation to access concept and security
• Presenter, speaker, (SAS Stockholm; Allan Lloyd Amsterdam; DIA data Madrid, DIA Barcelona, ERES Roche)
• Vendor Audits and Quality Reviews
• Concepts for quality management system, CAPA system, Change management, ISO9001:2015
• Process management (Policies, SOP’s, SA entries, System Validation); Risk assessment and management; CAPA plans; create, review and approval); Equipment (inventories, qualification, validation); Documentation, Templates; Training (GxP, CSV, CAPA, Company rules, Project management methodology)
• Variety of work, IT projects, lab projects (pathology, CPU, MML, Cll8, DNA, RNA), clinical trials (end point adjudication, CLL8, CLL2, Mabthera, Avastin, MAIN Avastin), Web site, CRO’s, CPU’s, from overall validation to access concept and security
Ausbildung, Diplome & Skills:
z.B. "Bachelor"
