Christopher James D.

Assistant Production Manager at Dispo-med
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Contact Information
us****@****om
(386) 825-5501
Location
Shah Alam, Selangor, Malaysia, MY
Languages
  • English -
  • Mandarin -
  • Malay -

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Credentials

  • Developing SQL Databases
    SQL
    Apr, 2022
    - Oct, 2024
  • Data Integrity Alcoa & Alcoa+
    Biocon
    Aug, 2019
    - Oct, 2024
  • Introduction to ISMS Standard ISO 27001:2013
    Biocon
    Aug, 2019
    - Oct, 2024

Experience

    • Medical Equipment Manufacturing
    • 1 - 100 Employee
    • Assistant Production Manager
      • Jan 2022 - Present

      Responsible for production planning, controlling of production output to meet delivery and quality expectations. In charge of preparation of raw materials and components for the next customer product orders. Managing the production inventory & warehouse management (raw materials & finished goods) and FIFO. Established quality SOP to ensure productive manufacturing environment and to meet within budgeting cost. Achieved customer satisfaction through quality management and timely deliveries. To prepare, review and revise ISO:13485 Regulation, BOM, QA/QC, Working Instructions related production documents. To organise machinery team and assembly team for ease of production flow. Leading lead engineer and line supervisor to carry out their tasks & teams properly in the manufacturing line and assembly line. Experienced in dealing with CE mark, ISO13485 & customer appointed auditors to meet their requirements. Show less

    • Spain
    • Biotechnology Research
    • 1 - 100 Employee
    • Manufacturing biotechnologist
      • Apr 2018 - Nov 2021

      Executed process and monitored batch manufacturing according to the planned schedule. Involved in the Cell separation team with an Upstream and Downstream process knowledge. Compliance in current Good Manufacturing Practice (cGMP) and Good Documentation Practice (GDP). Knowledge in handling (DCS) Distributed control system such as ABB & GEA separator systems as well as batch harvesting, pH adjustments, cell separation and Clean In Place (CIP) Operations. Adherence to SOPs, EHS, Change management and Data Integrity procedures. Involved in Building maintenance and Preventive maintenance of equipment. Knowledge in document review and deviations report for rectification through CAPA. Executed Qualification for line clearance and Validation Protocols as per plan. Knowledge in revising new version for Standard Operating Procedures, Equipment Operating Procedures and Batch Manufacturing Records for ease in production flow. Troubleshooting process operations for critical situations in related valves, pipelines and sequences errors. Familiar in SAP (Systems Applications and Products) for requesting raw materials, batch calibration and notification for maintenance. Experienced audits such as the U.S. Food and Drug Administration (FDA), National Pharmaceutical Regulatory Agency (nPRA), European Medicines Agency (EMA) and Agencia Nacional de Vigilancia Sanitaria (ANVISA). Show less

    • Malaysia
    • Higher Education
    • 700 & Above Employee
    • Research Intern
      • Feb 2016 - Apr 2016

      Conducted research related to the renal effects of Roselle in a Rat Model with diet induced obesity. Conducted lab experiments and chemical tests according to final year project. Processing chemicals needed for effective treatment of the Rat Model to achieve suitable results. Conducted research related to the renal effects of Roselle in a Rat Model with diet induced obesity. Conducted lab experiments and chemical tests according to final year project. Processing chemicals needed for effective treatment of the Rat Model to achieve suitable results.

Education

  • Manipal International University
    Bachelor's degree, Biotechnology
    2013 - 2017
  • NEXT academy
    Quantum Degree, Web development
    2017 - 2017
  • Sunway University
    Monash University Foundation Year (Science)
    2012 - 2013

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