Wendy Eng Kim Wei Email & Phone Number

Singapore

Mar 2014 - June 2017 – Document Control Specialist IJuly 2017 - Nov 2018 - Document Control Specialist IIDec 2018 - Present - Senior Quality Ops Analyst •Document and Change Management-Subject matter expert of document database system - Agile and SAP PLM tool and local site document management.-Support system migration project.-Train and coach new document coordinator on processing Document Engineering Request.-Review and process Document Engineering Request.-Develop and maintain control of hardcopy document process to ensure printed documents used at operation area are in latest version.-Develop and maintain local document master list using SAP PLM tool.-Work closely with HQ Document Management team to ensure process alignment and gaps improvement between sites. Revise and/or develop new global work instruction for gap closure and implement.•Training Management-Subject matter expert of training database – Learning Management System (LMS) tool and local site training program. -Support system migration project.-Train local team member from different functional areas who request LMS Security Role.-Develop and maintain local training matrix.-Lead training effectiveness project locally.-Drive training initiatives with global training team across sites and lead implementation locally.-Initiate and lead improvement activity for existing training process such as creating certification auto-assignment by LMS using business title.-Work closely with HQ Training Management team to ensure process alignment and gaps improvement between sites. Revise and/or develop new global work instruction for gap closure and implement.•Product Safety Compliance-Support HQ Regulatory team on change notification by providing documents/records.-Establish guideline on how to perform change assessment on product safety for document coordinator and change analyst.•Conduct internal audit and participate in third party audit (such as ISO notified bodies and customer audit).

Malaysia

• Provide QA support to subsidiary companies.- Develop and establish QMS documentation such as System Procedure, Work Instruction and Quality Plan- Conduct internal audit and participate in ISO and FDA audit • Responsible to manage document control for proper control of documentation.- Harmonize Tier 1- Quality Manual and Tier 2- Procedure to have shared document for commercial office at different sites- Develop and establish QMS documentation for new manufacturing plant• Responsible to performing data analysis for continuous improvement and provide input to management review.• Support Quality Improvement project at manufacturing site using fish-bone diagram and 5-why tool• Knowledge of handling 8D customer complaint and process validation.

Bachelor’S Degree, Chemical Engineering, 3.23

Pre-University, Biology, General, 4.00