Experience

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  PREMIER DIAGNOSTICS SDN BHD

  • Shah Alam, Selangor, Malaysia

  • Operations Manager

    • Mar 2019 - Present
    • Shah Alam, Selangor, Malaysia

    - Monitor company operation including Human Resources, office infrastructure and maintenance.- Main Coordinator for regulatory involving importation and distribution of diagnostic products in Malaysia.- Prepare registration documents & submission of medical devices under MDA- Renewal of registration for medical devices - Liaise with Principals, Regulatory board, on regulation requirements and necessary documents. - Responsible in overseeing ISO 13485 & Good Distribution Practice (GDP)- Complaint's coordination and Field Safety corrective Action (FSN, FCA & Recall). - Management Representative for ISO 13485- Understanding regulations involving importation and distribution of in Vitro Diagnostic products in Malaysia. - Compile and maintain documentations for ISO 13485 & Good Distribution Practice (GDP). - Maintain up-to-date information on regulatory requirements and regulations. - Handling ISO 13485 & GDPMD internal audit and external audit. - Ensure warehouse comply to ISO 13485 & GDPMD requirement.

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  All Eights (Malaysia) Sdn Bhd

  • Selangor, Malaysia

  • Regulatory Affairs Executive

    • Nov 2010 - 2019
    • Selangor, Malaysia

    1) Main Coordinator for regulatory involving importation and distribution of diagnostic products in Malaysia. - Registration submission of medical devices - Renewal of registration for medical devices - Liaise with Principals, Regulatory board, on regulation requirements and necessary documents. - Engage and liaise with CAB regarding medical device verification and full assessment - Maintain database of registration status for products. - Handling Exemption Order Notification 2) Responsible in overseeing Good Distribution Practice (GDP) including - Complaint's coordination and Field Safety corrective Action (FSN, FCA & Recall). - Management Representative and contact person of MDA - Understanding regulations involving importation and distribution of in Vitro Diagnostic products in Malaysia. - Compile and maintain documentations for Good Distribution Practice (GDP). - Maintain up-to-date information on regulatory requirements and regulations. - Apply and renewal of company Establishment License under MDA. - Handling GDPMD internal audit and external audit. - Ensure warehouse comply to GDPMD requirement. 3) Customer Service and Warehouse Team Leader- Monitoring stock level and expiry - Review inventory and to order - Order taking and processing (SO, DO, Invoicing)- Oversee warehouse facilities and maintenance- Customer follow-up and liaison, attend to enquiries on products- Handing disposal of medical devices- Manage logistics related to Suppliers & Manufacturer4) Coordinator Occupational Safety & Health Act (OSHA) - Prepare Safe Work Procedure - Ensure comply to OSH Act, established, implemented and maintained (SOP) - Company First Aider (with certified by CERT Academy 17 April 2021.

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  Pathology and Clinical Laboratory

  • Selangor, Malaysia

  • Biochemist

    • Mar 2003 - Nov 2010
    • Selangor, Malaysia

    - Assistant to Head of Department.- Responsible for running of the Immunoassay section.- Ensure that service and maintenance on all instruments in Immunoassay section are performed according to schedule.- Monitor instrument, quality control and assay performance.- In charge of reagent requisition and reagent inventory in Immunoassay section.- To assist in Immunoassay section staff training and annual staff appraisal.- Any other duties assigned by the management.- Update ISO 9001:2008 & ISO 15189 for Immunoassay section.- Other duties as for scientists.