APAC Quality Assurance Specialist

2 days ago


Kowloon, Hong Kong SAR China Guerbet Asia Pacific Limited Full time

APAC Quality Assurance Specialist (Regional role) Serving as the Quality Contact Point for internal stakeholders and external partners for local and APAC, this position will ensure effective operational and quality compliance across the local and APAC repackaging and distribution network. Main Responsibilities Deputy Person In Charge (PIC) of the Wholesaler Drugs Licence (WDL) licence Support the APAC QA Manager with quality assurance functions, including the handling of change controls, product complaints, deviation and CAPA, and deliver trainings. Ensure all work carried out in distribution and packaging is in compliance with the required standards conforming to company, cGxP, SOPs. Coordinate with warehouse operators, secondary packagers, third party suppliers and various stakeholders to ensure the logistics and packaging operations meet the quality requirements. Support the management of product quality complaints and distribution complaints, and track complaint responses in a timely manner. Support internal & external audits. Review and create SOP, GXP documents and records. Lead and be responsible for quality related tasks and projects as appointed. Responsible for the coordination with affiliates to ensure GXP and regulatory requirements are fulfilled. Ad hoc projects appointed by APAC QA Manager. Requirements Bachelor’s degree in science or related fields At least 4-5 years working experience in QA or RA Excellent communication and presentation skills in Chinese & English Detail‑minded, careful planning to achieve accurate and timely results Ability to work independently Experience with SOP and QMS development and implementation SAP experiences will be an advantage Benefits 13th‑month salary Clinical and dental coverage for staff and dependants Annual medical check‑up Annual leave Birthday leave Compensation leave We offer a competitive compensation and benefits package to qualified applicants. Interested parties please submit your application by clicking the “Apply Now” button. For more information about Guerbet, please visit our website: All personal data collected will be treated with strict confidentiality and used solely for recruitment purposes. If you are not contacted within 2 months of the closing date of the advertisement, please consider your application to be unsuccessful. #J-18808-Ljbffr



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