Gordon Kwong

Experience

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  Intellipharmaceutics International

  Feb 2006 - Apr 2009

  Senior Analytical Chemist and A/QPIC

  • Participated in the development, validation, verification, and execution of analytical procedures for raw materials and formulated products for drug development projects.• Authored testing protocols and reports, Standard Operating Procedures, and Standard Testing Methods. • Extensively involved in the physico-chemical testing of raw materials according to pharmacopoeial methodology. • Involved in testing in-process materials, and formulated products under stability program.• Responsible for conducting preformulation studies and reporting of found data. • Provided extensive calibration and maintenance activities to analytical instrumentation and equipment. • Maintained Quality Control laboratory documentation, filing, and records system.• Supported Quality Assurance in audits and investigation initiatives. • Managed laboratory procurement and inventory programs.• Trained and mentored laboratory staff on analytical methods and procedures. Show less

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  DKSH Healthcare

  Jan 2011 - Jul 2013

  • DKSH Regional Internal Auditor, audited Distribution Centers throughout Southeast Asia and Indochina: - Enhanced Operation systems and Quality standards in line with Regional guidelines- Identified improvement opportunities and recommended solutions • Successfully executed the 7S warehousing methodology in the Distribution Center and chaired the 7S Committee• Quality and Operations Lead for Macau operations: - Upgraded the Quality and Operational systems to meet regulatory requirements- Championed the continuous quality improvement of the Macau sub-distributors to satisfy client needs• Principal investigator for Cold Chain Delivery Management issues• Managed the Warehouse Sanitation Process to safeguard product quality and integrity• Optimized warehouse storage capacity through document archiving and gimmicks clearance• Responsible for warehouse improvement and regular maintenance in the most cost-effective way• Performed storage bin location maintenance to ensure stock integrity & accuracy Show less • Co-founder of the Quality Committee, consisting of Quality and Operations professionals to enhance business processes and communications• Created the Cold Room Failure Contingency Plan to respond to Cold Chain storage failure, regarded as the Regional Best Practice at DKSH• Enhanced profitability of the Redressing Department through process improvement measures and revised pricing schemes without compromising product quality• Developed and implemented Quality Assurance programs for Healthcare Warehouse to meet client and regulatory requirements• Led the Quality System and Qualification & Validation Teams through resource management and continuous improvement opportunities in the Healthcare warehouse• Involved in the attainment of ISO 13485• Handled ISO/GMP/client audits, deviation handling, change control and risk management• Conducted internal audits and inspections of the warehouse • Liaised with warehouse management team to address deviations and non-compliant matters• Provided training on Quality Assurance and Standard Operating Procedures (SOP) standards• Authored and continuously updated SOPs Show less

  • Assistant Operations Manager

    Jul 2012 - Jul 2013

  • Assistant Quality System Manager

    Jan 2011 - Jul 2012
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  Merck Group

  Jul 2014 - May 2019

  Quality Assurance Manager - Biopharma and Consumer Health Divisions

  - Ensure a quality system is established and maintained according to Merck quality standards according to GxP, ISO and local Hong Kong regulatory requirements.- Handling and investigating Complaints and Deviations within a timely manner and assuring related CAPAs are defined, documented and timely implemented to ensure continuous improvement and no recurrence.- Managed subsidiary’s compliance with HKDoH Wholesale Dealers License Code of Practice in good standing to support the business’ ability to apply import/export licenses.- Perform Quality Risk Assessment on local GMP/GDP operations to identify areas of improvement and formulate appropriate CAPA with cross-functional team to mitigate the identified risk(s).- Release shipped products delivered to the Hong Kong market and ensure that they are manufactured and shipped in line with Marketing Authorization and specifications, and on behalf of other APAC markets.- Product development of OTC goods for Consumer Health Division, including raw material and final product specifications, technical aspects of production, method development and validation testing. - Actively handled new product launches as a core member of the local launch team for Diabetes, Oncology and Neurodegenerative therapeutic goods in collaboration with global manufacturing sites, commercial entities and health authorities. - Successfully supported local and regional project team in 3/4PL tendering process, streamlining secondary repackaging and warehouse & distribution operations to better suit business growth, commercial strategies without any impact to business continuity.- Plan and execute routine audit of CMOs, 3/4PLs, packaging material providers and testing laboratories according to Merck Quality Standards, ISO and GxP standards.- Provided regional audit support for other Merck QA countries encompassing manufacturing sites and warehouse and distribution facilities within APAC. Show less

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  CSL Behring

  Jun 2019 - Feb 2021

  Senior Auditor - External Supply Quality Assurance, Global Quality APAC

  - Perform raw material, packaging material, manufacturing consumable and laboratory service qualification and requalification audits across 9 markets in APAC: China, Hong Kong, Indonesia, Japan, Malaysia, Myanmar, South Korea, Taiwan, Thailand. - Conduct audits for Asia sub-region Commercial Operations (China, Hong Kong, South Korea, Taiwan, Japan) by performing quality management system audits on pharmaceutical distribution service providers. - Lead Auditor for planning (based on risk-based approach) and executing routine and qualification audits of raw material, laboratory service providers, manufacturing equipment and consumables suppliers, 3/4PLs, packaging material and packaging service providers, plasma banks and fractionation service providers according to CSL Quality Standards, Quality Agreements, ISO 9001, ISO 13485, GMP, GDP, GLP, GxP and ISO 17025 standards.- Perform due diligence audits of prospective suppliers in collaboration with CSL stakeholders such as commercial operations, supply chain, business development and local country quality assurance departments. - Responsible for reviewing and creating global and local supplier quality agreements, for continuous alignment of current quality criteria and specifications between CSL manufacturing sites and service providers/suppliers whilst maintaining regulatory compliance. - Support CSL Global Manufacturing Sites in preparation for regulatory inspections.- Maintain CSL Approved Supplier List in accordance to CSL global policy to ensure compliance with regulatory authorities across markets. Show less

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  GE Healthcare

  Jan 2022 - now

  Head of Distribution Site Quality APAC and Quality Lead Hong Kong (Pharmaceutical Diagnostics)