Yvonne Wang

QA/RA Manager at Artron Laboratories Inc.
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Contact Information
Location
Richmond, British Columbia, Canada, CA
Languages
  • Chinese Native or bilingual proficiency
  • English Professional working proficiency
  • Cantonese Native or bilingual proficiency

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Experience

    • Canada
    • Biotechnology Research
    • 1 - 100 Employee
    • QA/RA Manager
      • Jun 2021 - Present
    • Canada
    • Health, Wellness & Fitness
    • 1 - 100 Employee
    • QA/QC Associate
      • Oct 2019 - Jun 2021

      QA Parts: •In charge of the maintenance of the quality system, records, and corporate documentation. •Review and author SOPs, equipment, facility, utility, test methods, and process validation / qualification protocols and reports. •Perform inspection for production activities to ensure GMP compliance. •Inspect and sample all incoming intermediate products and prepare the sampling reports. •Implement quality policies by facilitating and enforcing supportive activities from staff at all levels within the corporate structure. •Check reports, records and data for completeness and accuracy as well as to confirm compliance with internal procedures and regulations. •Work with production for the new production machine set-up and validation. •Maintain the HACCP plan and food safety internal auditing program. QC Parts: •Assist in the Laboratory start-up program, communicate with supplier for the instruments purchase. •Be in charge of the validation of new laboratory instruments, like autoclave, purified water system and HPLC. •Assist in the troubleshooting of laboratory instruments. R&D Parts: •Formulate new and existing natural health products. •Work closely with team members and departments to coordinate and execute commercialization of new products and processes. •Provide technical and troubleshooting assistant for formulation and production scale-up. •Apply NPN for new products registration, and amendment for old products as well. Show less

    • Canada
    • Pharmaceutical Manufacturing
    • 1 - 100 Employee
    • QA/QC Inspector
      • Nov 2018 - Oct 2019

      •Inspect all incoming and outgoing finished products and packaging components and their specific documentation for consistency, according to predetermined established standards and guidelines.•Sample sort, test, and inspect finished products.•Perform inspection for production activities to ensure GMP compliance.•Store Retained and Stability samples per the quality system in place.•Review manufacturing Certificates of Analyses, completed Batch Records, and Classifications of Defects.•Prepare Raw Material, Packaging Material and Finished Product Specifications.•Assist in the investigation of production deviation, customer complaints and CAPAs.•Assist in ensuring that all received raw materials and packaging components are sampled and submitted to labs for testing.•Perform routine testes such as pH, moisture, gluten, flow, DT, bulk density. Show less

    • Material Sampler (FT)
      • Sep 2018 - Nov 2018

      •Inspect, sample, and test raw materials, packaging materials, and semi-finished bulk products.•Perform the quality tests on incoming materials, like gluten test and bulk density test.•Perform the laboratory test for intermediate products, like weight variation tests for tablets and capsules, dissolution and disintegration tests for tablets, pH test for finished good products.•Maintain the sampling reports and log book.•Support senior QA for material deviation investigation and CAPA action.•Report any non-conformity or defect of incoming materials to senior QA. Show less

    • Pharmacy Associate (PT)
      • Aug 2018 - Apr 2019

      •Ensuring the information on the clients’ prescriptions is accurate, adding new prescriptions to their file. •Receiving prescriptions and ensuring their authenticity. •Reviewing customer files and updating them with any changes in personal information or medical condition. •Receiving payment from customers, completing insurance forms and contacting insurance companies whenever necessary. •Assisting the Pharmacist during health checks, helping during procedures such as pregnancy tests, checking cholesterol and blood pressure, and screening for diabetes. •Sending prescriptions to other pharmacies and providing them with any additional instructions regarding the patient’s condition, preferences, or habits. •Keeping an inventory of medications and pharmaceutical products. •Maintaining database, ensuring all prescriptions are properly digitized and organized. •Maintaining product displays and performing any other related duties, as assigned. •Carrying out administrative and bookkeeping tasks when required. •Complying with company or hospital standard operating procedures, policies, professional standards, and applicable laws and regulations. •Staying updated on pharmacy regulations, treatments, and developments. Show less

    • Quality Assurance Compliance Specialist
      • Aug 2013 - Jul 2017

      Document Control Specialist •Number, issue, revise and archive official documents. •Facilitate the SOP approval process by calling meetings to review, edit and approve SOPs. •Monitor and update status of deviation report, change control and CAPA. •Maintain the SOP index and document SOP updates. •Manage the annual archival and destruction of records in accordance with GSKs global records retention policy. Supplier Quality Management Specialist •Documentation on such relevant supplier forms, like Supplier Desk Audit, Quality Agreement, Supplier Change Control, Deviation, CAPA, Supplier Approval List, audits requests, escalation to the Global Supplier Quality Operation and complaints handling for suppliers (raw materials, packaging materials, consumables) & 3rd parties / services providers from a quality point of view for the purpose to guaranty conformity with GMP and GSK requirements. •Author and review Standard Operating Procedures related to QA supplier activity. •Periodically report KPIs for QA Suppliers activity. •Lead self-inspection and internal audits for the purpose to identify any non-compliance to the GSK, QMS, GMP, GDP and local SOPs. •Support Inspection / Audit by local Health & Drug Authorities and GSK group, prepare audit and inspection answers, follow action plan and document action closure. •Perform annual on-site audit for suppliers / 3rd parties / service provides, write the audit reports and follow up the CAPA actions. •Ensure that all records (Deviations, CC, CAPAs, etc) in which QA supplier oversight is involved is completed appropriately according to local SOP and on time. •Perform Quality Risk analysis for suppliers (Raw materials, packaging material, consumables) and 3rd parties/service providers. •Provide to affiliate and regulatory department all necessary support and documentation as per request •Point of contact with Global Supplier Quality Organization •Participate to the Supplier Integration Program between GSK and Novartis. Show less

    • United Kingdom
    • Higher Education
    • 700 & Above Employee
    • Graduate Student Research Assistant
      • Aug 2011 - Nov 2012

      Project: Identification in Metabolites Department: Strathclyde Institute of Chemistry and Cancer Research Center Job Descriptions: *Prepared blood samples and centrifuged the serum, then recorded the original data of concentration *Performed analytical instruments HPLC-MS and GC-MS *Designed and conducted available methodologies by Pipeline Pilot to achieve effectively filtering in peaks Results: Successfully filtered 90% false peaks and background noises from 5000 peaks, totally kept the true peaks in the original peaks Show less

Education

  • Univeristy of Strathclyde, United Kingdom
    Master of Science (MSc), Pharmaceutical Analysis
    2010 - 2012
  • Guangdong Pharmaceutical University
    Bachelor of Science (BSc), Pharmacy
    2005 - 2010

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