Freelance Consultant QA Expert (w/m/d)

•             Maintain of quality management system

•             SOP and Training management

•             Local GDP Regulatory intelligence and quality alert monitoring

•             Handling change control, non-conformities, complaints, CAPA

•             key performance indicators (KPIs) and collecting quality-related data for processes at local level

•             Qualification and oversight of local suppliers and local customers

•             Reconciliation of Post-Marketing Surveillance Unsolicited Information

•             Perform Risk Assessment

•             Self-inspection and audit to Local supplier (e.g. 3PL)

•             Local Quality Management review

•             Readiness management in case of Local HA/Partners/HQ inspected/audited