QA-Manager

ComplianceSupport, Life-cycle-management, ALM/PLM, Datamigration,
Project Management; Business Analysis, CAPA,

GAP-Analysis and Remediation, Business Analysis/Requirement Analysis and Specification for database supported solution,
 Risk-analysis and – management, Root Cause Analyse, Process-analysis, Request management, Change- and Configuration Management, Problem-&Incidentmanagement, Document management, support for technical documentation DHF, DMR, DHR; Quality Assurance,
CSV, Qualification, Processvalidation, Method-validation, DataIntegrity
Material and equipment management, Information Integration,

for Business:                       
Pharmaceutical & Chemical Industry/Life-Science/Science
Telecommunication/ Logistic / Software development projects - Federal Administration, Government,
Fine mechanics / Medical devices / IVD, Finance / Software development, Building Construction / Documentmanagement

Methods/Skills:
Quality management ISO 9000 pp; GxP, GAMP5, FDA, DIN EN 62304, ISO 13485, ISO 14791, ISO 10993, 21 CRF Part 11, 210, 211,106,107, 110, 801, 820-822 - for Class C device, 510(k), SOP, ICH 7-10

Knowledge in Laboratory methods, Molecular biology & Microbiology

Oracle, mySql, Access, php, xml, html....
SAP..

Further information after request