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Chin Han Fong is a seasoned quality and regulatory professional with 15+ years of experience in pharmaceuticals and life sciences. He has expertise in GLP, GMP practices, HPLC, dissolution, analytical chemistry, and cleaning validation. Chin has held senior roles in companies such as Tessa Therapeutics Ltd, MSD, and M-Univac Sdn Bhd, where he has led global LIMS deployments, validated lab systems, and managed quality programs. He holds a Bachelor's degree in Industrial Chemistry from Universiti Teknologi Malaysia and various certifications in time management, strategic focus, agile coaching, and ScrumMaster.

Credentials

  • Time Management for Managers
    LinkedIn
    Dec, 2023
    - Apr, 2026
  • Strategic Focus for Managers
    LinkedIn
    Nov, 2023
    - Apr, 2026
  • Agile Coaching (ICP-ACC)
    ICAgile
    May, 2021
    - Apr, 2026
  • ICAgile Certified Professional - Agile Team Facilitation
    ICAgile
    May, 2021
    - Apr, 2026
  • Certified ScrumMaster (CSM)
    Scrum Alliance

Experience

    • Senior Expert
      • Jun 2021 - Present
      • Singapore

      Commission, qualify and validate Facility, Utility and Equipment (FUE), enterprise SAAS softwares, and standalone computerised systems using ASTM E2500 risk-based approach.

    • United States
    • Pharmaceutical Manufacturing
    • 700 & Above Employee
    • Senior Specialist
      • Sep 2016 - May 2021

      • Lead and manage Global LIMS deployment for Singapore site. • Lead mitigation activities for Data Integrity observations for Lab Systems. • Validation of Lab computerised systems. • Core data team for site deployment of Global SAP. • Oversee drug product stability program administration.• Involved in site wide lab system recovery post cyber-attack.• Residual solvent method validation and verification for drug product.

    • Chemist
      • Sep 2008 - Aug 2016

      • Support drug product release testing (nasal sprays, capsules/tablets).• SME for HPLC, dissolution systems, stability chambers. • Support manufacturing equipment cleaning monitoring and validations.• Manage lab investigations. • Manage drug product stability program.• Maintain LIMS data base. • Qualified computerised lab systems. • Involved in method transfers.• Involved in equipment surface recovery studies.

  • M-Univac Sdn Bhd
    • Johor, Malaysia
    • Supplier Quality Engineer
      • Jun 2007 - Aug 2008
      • Johor, Malaysia

      •Leading technicians to ensure good quality of products delivered to customers (using visual inspections, dimension measurement, force test). •Perform measurements on finished products to ensure dimensions are within specifications (using micrometer, caliper, dial indicator, pin gauge, block gauge, smart scope).•Perform investigations on product quality issues, proposing and monitoring of corrective actions.•Managed and controlled inventories of on hold or rejected goods with proper segregation and 5S. •Involved in study of packaging of finished goods (using drop test).•Involved in study of properties of plastic (using force test).

Education

  • 2004 - 2007
    Universiti Teknologi Malaysia
    Bachelor's degree, Industrial Chemistry

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Industry Focus. “Biotechnology Research”

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