GMP equipment documentation, Qualification expectations, Pharmaceutical sterile manufacturing equipment, Cgmp, Fluent Mandarin, Lyophilizers, Critical utilities, Aseptic fill-finish

trackwise , SAP, Basic Troubleshooting, Ms Office, Cgmp, Lims

trackwise , Sap Qm, Microsoft Office, risk management, quality metrics reporting, Iso 13485, 21 CFR Part 820, Root Cause Analysis, cGMP regulations, Capa, Change Control, statistical analysis tools, Quality Systems

Iso 13485, EU MDR, FDA 21 CFR Part 820

Quality Management System (QMS), statistical process control (SPC), New Product Introduction (NPI), Iso 13485, Quality Management

Problem Solving, risk assessments, Iso 13485, continuous improvement tools, SCAR, Fmea, Non-conformance Handling, FDA 21 CFR Part 820, Risk Management, Capa, component qualification, supplier management processes, audits

MDSAP, Iso 13485, ALCOA plus, EU MDR, Gmp, Data integrity principles