Sean Tee Seng Tea

Experience

• 

  Malaysian Electronics Materials Sdn Bhd

  Nov 2005 - Nov 2012

  Senior Quality Assurance Engineer

  Roles & Responsibilities:o Interpret, setup, implemented and maintained of international management system – ISO/TS 16949, ISO 14001, OHSAS 18001, ISO 9001 QMS systemo Managed the investigation of product complaint from customer, implement CAPA and replied the complaint to customero Analyzed the production process (input/output) with statistical software, recommended improvement plans to Productiono Performed audit (internal, external) as required by the QMSo As an subject matter export (SME) for local change controlo qualitative and quantitative risk management including HIRADC, HAZOP, QRA etc for OHSAS 18001 systemo Been learned the proper methodologies to control hazardous waste and how to ensure sustainable development through process engineering and life cycle management.o Well understanding of safety, health and environmental laws in Malaysia Show less

• 

  Bayer Co. (M) Sdn Bhd

  Nov 2012 - now

  Quality Assurance Manager

  Roles & Responsibilities: o Implemented the GxP (GDP/GMP) & GDPMD / GDPMDS concepts and processes in the commercial operation in cluster countrieso Audited and qualified the service providers (warehouse / distributor / repacker) for outsourced GDP / GMP and GDPMD activities o Coordinate repackaging activities such as provide QA SOP / repackaging & relabeling instruction, internal processes, local requirements, batch release approval, documentation and retention of sample with local warehouseo Led the audit program (external (service provider / Health Authority, internal, Global), either be the auditor or auditee during the audit processo Following-up and closure of the CAPA for finding issued in the audits or gaps identified in the operations o Act as process owner or subject matter expert for QA processes, relevant trainings were conducted for internal / external stake holders according to training matrix / plan.o Handled deviations from manufacturing site, transportation or service providers o Act as local quality oversight person for GDP/GMP processes (incoming, transport temperature, repack/relabel) in local warehouses for products imported and marketed in the countries o Led the critical product issue in the countries such as product recall, suspected counterfeit, critical product complainto Accountable for product technical complaint, from receiving, complaint sample handling, closure and reply to customero As the owner of Quality Assurance Agreement (QAA) between the organization with Global / product supply, service providers, which to be updated and maintained. Create new QAA when needed.o Management of change control for local GMP/GDP/GDPMD/GDPMDS processeso Update and maintain the local regulations and external requirements, perform gaps analysis and update local QMS system from time to timeo A Radiation Protection Officer (RPO) registered with the Authority (AELB), Designated Person for Establishment License for medical device Show less