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Quality Sys Spec

2 weeks ago

Kowloon, Hong Kong SAR China Bio-Rad Pacific Ltd Full time

How You’ll Make an Impact: Quality Compliance Activities Support the setup, maintenance and ongoing management of distributor and importer quality systems, in accordance with the Code of Practice for Listed Distributors and Importers of Medical Devices for the Hong Kong Service Center. Ensure the implementation of appropriate control measures for ordering, supply and distribution of medical devices to authorized customers and distributors. Attain and maintain necessary licenses and permits including: Antibiotic Permit, Wholesale Dealer Licence(s) for Poisons, Wholesale Licence(s) for Dangerous Goods Part 1 and Psychotropic Drugs, as applicable, Import Licence(s)/Certificate(s) for Dangerous Goods Part 1 and Psychotropic Drugs, as applicable. Work closely with regulatory bodies during audits and inspections, resolving issues and implementing changes to ensure compliance and smooth operations. Support the setup and implementation of Hong Kong Good Distribution Practice (HK GDP) standards. Conduct routine checks for updates in relevant legislations and ordinances, such as CAP 134 Dangerous Drugs Ordinance, CAP 138 Pharmacy and Poisons Ordinance and CAP 137 Antibiotics. Review and update Standard Operating Procedures (SOPs) and Work Instructions (WIs) to reflect any newly controlled substances or regulatory changes. Manage and control drug fulfilment processes, including physical handling, record-keeping and ensuring data integrity of drug records in Hong Kong. Apply critical thinking and problem‑solving skills to identify root causes of issues and implement corrective actions effectively. Support in any relevant activities, as assigned. Quality Assurance Activities Support activities related to nonconformance, corrective actions and effectiveness checks. Collaborate with service center personnel to continuously improve quality procedures and methods. Perform activities related to quality assurance functions, including document inquiry, retrieval of archived records, management of electronic records, SAP transactions related to Quality Notifications. Conduct audits and oversight of third‑party wholesale distributors and importers, supporting internal and external audit processes. Draft, revise or obsolete controlled documents used at the service center. Apply and maintain the relevant licenses in Hong Kong. Find the gap between regulations and current quality management system, work out solutions and implement. Oversee and audit the 3rd party vendors to ensure the wholesaling and import licensing activities are covered. Setup and maintenance of the distributor and importer Quality system requirements at the Hongkong service centre. Be responsible for operational related CAPA plan and perform activities related to nonconformance, corrective actions and effectiveness checks. Be responsible for establishment, maintenance and optimization of the local SOPs. Perform or support in internal and external audit of quality management system for the service center. Organise and conduct quality related training to employees and distributors. Prepare, maintain and update library or external regulatory standards, reference and guidance documents. What You Bring: Minimum bachelor's degree in pharmacy (Hong Kong) or Internal auditor qualification preferred. At least 3 years' work experience in Quality Assurance and holding wholesale and/or import license for handling pharmaceuticals or medical device IVD. Experience in ISO9001, ISO 13485 &or GDP. Hong Kong Registered Pharmacist is preferred. Other knowledge, skills, abilities Proactive approach to resolving issues Good analytical, communication, problem solving, critical thinking, and computer skills Good working knowledge of regulatory requirements Working knowledge of policies, practices and procedures relating to Quality Assurance Good oral and writing English and Cantonese/Mandarin. #J-18808-Ljbffr