Tan Wan Yuen

Experience

• 

  Dynapharm (M) Sdn Bhd

  Jun 2017 - Sept 2017

  Quality Control Chemist

  Internship-Raw material inspection as per BP and USP specification-Conduct raw material and samples testing, such as identification test, viscosity, water content, loss on drying, sulphated ash, assay determination and so on. -Finished products testing, such as Thin-layer chromatography (TLC) -Preparation of analysis report as per GMP requirement-Preparation of standardized volumetric solution and intermediate chemical solution-GMP and safety training on Safety Data Sheet (SDS), Globally Harmonized System (GHS) Pictograms, and Personal Protective Equipment (PPE) Show less

• 

  Supervision Optimax

  Aug 2018 - Feb 2020

  Quality Control Engineer

  -To ensure the incoming, in-process and finished products meet the quality control standards through conducting validated inspection and procedures.-To assist in final approval of semi-finished and finished products for release.-To plan schedule and monitor the QA/QC activites including prepare related QA/QC documents required for product (e.g. NCR, COC, COA).-To review DHR to ensure production are running smooth and well documented.-To lead and monitor QC inspector teams to fulfill the required QC tasks.-Responsible for QC technical training and assessment for QC inspector team.-To report any quality issue during QC inspection to management and production team.-To liaise with other departments in solving products quality issue.-Responsible to keep all QA/QC information and record in an organized manner and updated regularly.-To participate in internal and external audit with knowledge of ISO 9001, ISO 13485 and MDSAP.-To review the customer complaint and CAPA regarding quality issue for improvement-To assist in engineering study for quality improvement of product and efficiency of process. -Environmental monitoring of cleanroom.-Air sampling with viable and non-viable air particle counter.-Surface monitoring with swab test & RODAC plates.-Perform microbiological testing (Product Bioburden & Product Sterility Test).-Water sampling testing.-Decontamination of microbiological/biohazard waste. Show less

• 

  OTC Cosmetic Industries Sdn Bhd

  Aug 2020 - Oct 2022

  - Involve in organization’s quality audit program, including GMP, ISO 9001, FCCA, C-TPAT, SMETA. HACCP, Halal, Disney FAMA, internal audit, and others- Ensure that the incoming, in process and finished product produced is fit, consistent and meets both external and internal requirements. -When there is a quality issues and nonconformance arise, immediate action shall be taken such as NCR to be issued and to further identify the root cause and corrective action. -Work closely R&D team to clearly define the product specifications are approve by customer while meeting the production process. Trial batch and packaging material testing according to production process compatibility for new product development. -To react and answering pertaining to customer complaints on the quality of products goods and finding solutions to meet their needs and expectations. -To highlight to supplier if the products spec received is not up the the required standard and to find a solution to settle it-Ensure safety practice is followed at all times at workplace (factory and warehouse)-Ensure safety signs or even precautions has been done accordingly. Also to do up a report on any accidental case happened whether in factory or in office-Monitoring company's surrounding environment to do up a pest control process when required from time to time to ensure company hygiene is there at all times-Conduct a product training whether is new or current and also other trainings on production related and also quality related matters to all employees.-GMP training, Halal procedure, regulatory compliance, product equipment calibration and also product development testing to all productions and operation related employees so that they are aware of the requirements towards the company mission and vision-Ensure and monitor the company schedule waste products to be kept updated and recorded-Monitoring WWTP practice to ensure it is on track and rectify when there is issues encountered. Show less -Involve in organization’s quality audit program, including GMP, ISO 9001, FCCA, C-TPAT, SMETA. HACCP, Halal, Disney FAMA, internal audit, and others-Ensure that the finished product produced is fit, consistent and meets both external and internal requirements. -Prepare the work instruction for production and ensure it is issue on time.-To lead and monitor QC inspector teams to fulfill the required QC tasks.-Issue the NCR for any non-conformity, such as incoming, in-process and finished product. -Handle the customer complaint with CAPA and product return/rework-Liaise with china regarding the product manufacturing, standard and requirement. -Prepare the COA for finished product. -Pest control monitoring-Revise and establish company’s SOP according to regulation requirement and internal improvement.-Conduct R&D packaging material testing during the product development stage.-Liaise with R&D and production team for product’s quality improvement.-Coordinate and monitor the PDC product, such as first production conformation, sample for customer, output and container loading photo. Show less

  • QA / QC Assistant Manager

    Jul 2022 - Oct 2022

  • QA/QC Executive

    Aug 2020 - Jun 2022
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  Yanling Natural Hygiene Sdn Bhd

  Oct 2022 - now

  -Guides, plans, and directs the RA staff to create and/or maintain compliance to the applicable regulatory requirements, including but not limited to product registration, halal application, variation and post market surveillance.-Dossier preparation and review prior to product registration of TMHS, OTC and Food labelling.-Liaise with relevant authorities and departments on matters pertaining to regulatory.-Provide guidance and support on regulatory matters to other departments and customer.-Keeping up to date with changes in regulatory legislation, guidelines and standard.-Find and study the scientific papers to support the safety dosage and claims for new products.-To maintain appropriate documentation and records related to regulatory submissions and approvals.-Support and coordinate post market activities, including post market surveillance, product variation, and recall management as required.-Act as internal auditor for ISO22000:2018, GMP and Halal.-Involve in the food safety and health, safety, and environment (HSE) management of the company.-Keep track of product stability data by working closely with QAQC team to ensure the product compliance throughout the shelf life. Any nonconformance to be highlighted to respected parties. Show less -Guides, plans, and directs the RA staff to create and/or maintain compliance to the applicable regulatory requirements, including but not limited to product registration, halal application, variation and post market surveillance.-Dossier preparation and review prior to product registration of TMHS and Food labelling.-Liaise with relevant authorities and departments on matters pertaining to regulatory.-Provide guidance and support on regulatory matters to other departments and customer.-Keeping up to date with changes in regulatory legislation, guidelines and standard.-Find and study the scientific papers to support the safety dosage and claims for new products.-To maintain appropriate documentation and records related to regulatory submissions and approvals.-Support and coordinate post market activities, including post market surveillance, product variation, and recall management as required.-Act as internal auditor for ISO22000:2018, GMP and Halal.-Involve in the food safety and health, safety, and environment (HSE) management of the company.-Keep track of product stability data by working closely with QAQC team to ensure the product compliance throughout the shelf life. Any nonconformance to be highlighted to respected parties. Show less -Dossier preparation for product registration of TMHS. -Liaise with relevant authorities and departments on matters pertaining to regulatory.-Provide guidance and support on regulatory matters to other departments and customer.-Keeping up to date with changes in regulatory legislation, guidelines and standard.-Find and study the scientific papers to support the safety dosage and claims for new products.-To maintain appropriate documentation and records related to regulatory submissions and approvals.-Support and coordinate post market activities, including post market surveillance and recall management as required. Show less

  • Assistant Manager, Regulatory Affairs

    Jan 2024 - now

  • Senior Executive, Regulatory Affairs

    Feb 2023 - Dec 2023

  • Regulatory Affairs Executive

    Oct 2022 - Jan 2023