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Experience

    • R&D QA Executive
      • Aug 2021 - May 2022
      • Singapore

      - Awareness of EMA, FDA, OECD GLP guidelines and any other relevant regulations and guidelines.- Establishment of Quality Management System based on ISO 17025 standard in a bio-analytical and bioassay testing laboratory- Support ISO/IEC 17025 accreditation and related activities- Conducts audits of studies and facilities for compliance to relevant regulations and report to Study Directors and Management- Conduct training for staff with emphasis on GLP, ISO17025 and other related regulations- Review SOPs and assist in writing Quality Assurance SOPs- Host regulatory inspections and follow up with national international regulation agencies as required- Responsible for CAR management (maintain an excel, track closing, follow-up on effectiveness of CA, analyse trends etc)- Responsible for Continuous improvement- QC verification- Regulatory Dossier Review- Support LIMS establishment and implementation

    • Senior Analytical Chemist
      • May 2017 - Aug 2021
      • Singapore

      - Lead a small group of lab analysts to applies GLP in all areas of responsibility and ensure smooth operation.- Organize, conducts and evaluates analytical results and testing independently in compliance with applicable methods, QMS protocols, SOP’s and regulatory agency guidelines.- Plans team members daily operation workload.- Documents work, maintains study documentation and laboratory works.- Independently sets-up, maintains, operates and performs routine and non-routine maintenance on laboratory equipment (ICP-OES and ICP-MS), including problem identification and resolution.- Performs peer review and QC review of data.- Recognizes deviations from normal results and inform Study Director, Principal Investigator and/ormanagement of any problems and/or deviations that may affect the integrity of the data and participates in corrective action of problems.- Initiates, drives and implements process improvement initiatives.- Assists in setting up and performing optimization, and validation of various analytes in a variety of matrices, and may assist in method development.- Participates in client visits as needed, assists in communicating technical information.- Assists in evaluation of data for incorporation of written lab investigation report.- Provides input and participates in project meetings, plans, monitors and guides project work.- Maintained the inventories of equipment spare parts, chemicals, laboratory consumables needed and placed ordered at appropriate time which helped to carry out the operation smoothly.

    • Chemist
      • Oct 2013 - Feb 2016
      • Singapore

      - Perform chemical analysis of water, wastewater and seawater samples.- Lead a small group of lab analysts to ensure smooth operation.- Continuous improvement of processes by Kaizen project.- Perform in house calibration, conduct performance checks, maintenance, troubleshoot and operation ofsophisticated laboratory instruments including IC, TOC, GCMS (Headspace and Ion Trap), FIA, UVSpectrophotometer, ICP-OES, and etc.- Prepare and updating of Work Instruction/ SOPs.- Develop new method if required.- Summarize analysis data and prepare Test Reports.- Arrange samples for proficiency test every year to meet SAC requirement.- Maintained the inventories of equipment, chemicals, laboratory consumables needed and placed ordered at the appropriate time which helped to carry out the experiments smoothly.- Improve lab throughput and efficiency by sourcing new equipment through different vendor. Decide andpresent to top management after comparing the specification, prices and services; as well as pre-qualify orpre-validate equipment’s performance prior final decision making.- To source for different vendor for chemicals and consumables, which have similar performance butcomparable prices; in order to ensure sufficient use for lab operation as backup plan, in case current supplier unable to deliver items on time.

    • Chemist
      • Feb 2011 - Oct 2013
      • Singapore

      - Provide technical and analytical assistant to customers and service engineers within an agreed time-frame and provide reliable results.- Quality assurance of raw materials, in process and final inspection of manufacturing products.- Troubleshooting and critical analysis of local manufacturing products.- Maintenance and operation of sophisticated laboratory instruments including HPLC, IC, GC-FID, ICP-OES, AAS, CVS, Auto-Titrator, Karl Fisher Titration, UV-Vis, VA, pH and etc.- Perform in house calibration and maintenance for analytical instruments.- Maintained the inventories of equipment, chemicals, laboratory consumables needed and placed ordered at appropriate time which helped to carry out the experiments smoothly.

    • Quality Assurance Executive
      • May 2008 - Feb 2011
      • Malaysia

      - Handles on company's green plan (Shimano Green Plan); ensure final products able to fulfil International Regulation requirement (eg. RoHS, REACH and CPSIA).- Studies and decides on monthly sampling plan.- Set up basic laboratory and instruments (EDX-GP and UV-1240).- Studies, troubleshoot and improves existing testing method in order to obtain more reliable result. - Understand and study the international regulation requirement.- Find out root cause and investigate the existences of banned substances in products.- Approve on First Articles’ (green compliance portion).- Conduct audit to low compliance supplier.- Handle and monitor on radiation safety in order to ensure safe use of EDX machine (X-ray).

Education

  • 2005 - 2008
    Universiti Teknologi Malaysia
    Bachelor's degree, Industrial Chemistry

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Industry Focus. “Pharmaceutical Manufacturing”

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