Quality Assurance

• Apr 2014 - Present

Quality Assurance Manager

• Jun 2007 - Jun 2012

• To developed and maintained Quality Management System: plan and conducting internal audits, identifying non-conformities and investigating the potential root-causes, managing the CAPA process, analyzing the data, conducting management review meetings, continuous improvement, review and updating the Quality Manual, policies and procedures, maintaining documents and records, ensure the calibration of equipments, handling customer complaints, supplier evaluation, identify training needs and conducting training. • Successfully managed the bi-anual ISO audits as well as customer audits • Led a fourteen member of QA team and ensured consistency across production lines through SPC, incoming, in-process and final products inspections. • Initial sample inspection and reporting • New product validation • Liaised with customer and supplier quality departments to resolve quality issues Show less

Quality Assurance Auditor

• May 2000 - Sep 2007

During this period I managed to work as a internal auditor while supervising the Final Release Checking section : • Planning and conducting internal audits; reporting NCR, investigating the root-causes, follow up the CAPA process and closing up NCR, analyzing the data for management review, supporting the QA & RA Manager during second and third party audits and handling customer complaints • Planning and organizing QC tests at the Final Release Checking section, including in-process testing and product release; in accordance with SOPs, cGMP and EU & ASTM standards,Compilation and assessment of release data for finished product, issuing Certificate of Analysis for each shipment, review and updating SOPs, managing the twenty members of QC team effectively and efficiently to identify process issues and achieve KPI’s and employee training & development. • Performed periodic glove sterilization validation and supported for new product validation and qualification activities • Planning and conducting sister plant’s sample testing (round robin test) and reporting • Member of company Six Sigma/continuous improvement project team Show less