GeschäftlichConsultant QA Support at Statens Serum Institute - SSI
Branche Medical / Health Care / Pharmaceuticals
Info I have over 20 years of experience with the QMS ISO 9001, ISO 13485 ISO 14971 EU GMP, FDA 21 CFR parts 4, 11, 210, 211, 610 and 820. I have strong background in QA/QC, Process Engineering, Project Management, Audit, Six Sigma, LEAN and Validation.
I can offer my Consultant services to the Clients within:
. Contract Qualified Person, Contract QA.
. Project Management, Audit, inspection, Supplier audit, QA/QC, GMP Training
. Perform Validation tasks within IT systems/Process/Equipment/Analytical Methods.
. Selection of new Contract Manufacturing Organisation and QA oversight.