Chiu Ann, Eng

Experience

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  Sensfab Pte Ltd

  Dec 2008 - Oct 2009

  Process Engineer

  -Planned, organized, and accomplished key project for product yield improvement and cycle time improvement.-Prepared and implemented evaluation for new material qualification to improve the quality of manufacturing. -Performed manufacturing line trouble-shooting by using Ishikawa diagram and resolved line issues in fast-paced environment.-Executed root cause analysis, implemented the containment actions and followed by CAPA program.-Prepared and revised product specification and related process instructions to ensure in line with company quality system requirement.-Provided process guidance and conducted training for operation personnel to reduce waste, reject rate and improve productivity. Show less

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  Kim Sin Medicine Manufactory Pte Ltd

  Feb 2010 - Mar 2012

  QA & Regulatory Compliance Engineer

  -Maintained quality system in line with PIC/S and ASEAN GMP standards and authority expectations through internal quality management system. -Evaluated quality of products through annual product review and stability studies.-Involved actively in quality improvement projects by using Six Sigma tools and evaluated the effectiveness of implementation.-Performed internal audits, GMP deviation investigation and followed up by CAPA program.-Prepared and implemented validation protocol for equipment, facility, manufacturing process, cleaning method and analytical method.-Prepared and executed Installation, Operation and Performance Qualification of equipment and facility.-Evaluated equipment performance and calibration results through SPC charts monitoring. -Trained and coached company staffs in order to compliance with GMP requirements and 6S principles.-Implemented risk assessment and evaluated the effectiveness of Risk Management.-Resolved customer complaints by using Root Cause Analysis and improved their satisfaction by Cpk.-Responsible for submission of product listing and documents control. Show less

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  Schenker Singapore

  Mar 2012 - now

  Assistant Manager

  -Ensure GxP regulated systems and ISO processes are in full compliance with regulatory requirements, company policies and procedures.-Liaise with respective department to prepare, review and implement quality plans, inspection plans & operational procedures in accordance to the technical specifications, customer’s surveillance requirements and regulatory compliance.-Work with customers, operation staff and suppliers to meet the quality requirements and to drive towards continuous improvement.-Perform internal audits (ISO 9001 and GxP) and coordinates external audits.-Review and ensure closure of non-conformance (NC), customer complaints, CAPA and 8D.-Train staff on Quality Management Systems and GxP requirements.-Maintain "Quality Issue Response System" on resolution status, cycle time taken and issue owners.-Analyse Customer Satisfactory Survey results and track for continual improvement till closure. Show less