**Primary Job Function:** Overall quality assurance responsibilities for all products of Established Pharmaceuticals Division in Hong Kong and Macau markets, work closely and cross-functionally with internal departments at local, regional and global level. The role also involves developing and implementing quality management systems to comply with corporate quality standards and regulatory requirements; handle internal and corporate audits as well as CAPAs and exceptions; driving continuous improvement in quality processes; participate in ad hoc project as and when required. Contract is renewable. **Core Job Responsibilities:** The core job responsibilities of a Senior QA executive typically include: Implementing and Maintaining Quality Management System + Maintain and improve Document Control System and Change Control System + Maintain and update QA documentation, including SOPs, working instructions and quality records + Perform ISOtrain training coordinator role, Monitor and update local training matrix according to corporate requirements, and ensure timely completion of required trainings + Assist in the implementation and maintenance of activities related to compliance to policies, processes, procedures and plans that define these elements necessary to meet the Quality objectives, along with Regulatory and business requirements + Assist in ensuring that quality related issues associated with products distributed I products distributed conform to current Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), Company Corporate and Divisional Quality standards, and other applicable regulatory standards in order to assure readily available supply of compliant, authentic, safe and efficacious products at market competitive cost + Provide support to other business functions in implementation of quality requirements Audits Participation + Handle internal and corporate audits, as well as CAPAs and exceptions + Assist in preparation for inspection by Department of Health (DH) Product Quality Complaints Handling + Register, handle and monitor product quality complaints and any other quality issues + Inform Affiliate Safety Representative (ASR) of all complaints related to adverse events (AE's) + Escalate issue related to counterfeit, diversions, tampering and theft Supplier Quality Management and Outsourced Activities + Implement Supplier Management Program in qualifying vendors and routine monitoring of vendors’ performance + Assist in establishing, maintaining and updating product specifications + Monitor and inspect incoming shipments and repackaging activities in third party warehouses, when required Quality Metrics and Reporting + Ensure implementation of quality procedures and metrics + Maintain Management Review process for Affiliate and elevate any significant events or identified risks to management Product Disposition and Mock Recall + Assist in executing quality hold, release or rejection of incoming products + Organize mock recalls as per schedule + Provide support to product launches through management of the First Lot Quality Review (FLQR) program, when required Others + Local travel to third party warehouses or vendors for all related quality activities may be required + Handle and resolve urgent quality issues, documenting decisions and all Agency communications /actions + Any ad-hoc task assigned by the management + Support other affiliate to perform QA major responsibilities may be required **Supervisory/Management Responsibilities:** Number of Employee: None Direct Reports: None Indirect Reports: None **Position Accountability/Scope:** + For implementing and maintaining QMS to comply with Abbott quality standards and regulatory requirements. Ensure the local processes and procedures are in place and follow throughout the daily operations. + Analyze data, identify areas for improvement, and implement CAPA to optimize processes and achieve quality objectives. + Identify and manage quality-related risks + Work closely with different departments to communicate quality requirements, address concerns or issues. **Minimum Education:** + Bachelor’s Degree in Pharmacy/ Food Science or equivalent disciplines **Minimum Experience/Training Required:** + At least 3 years of work experience in Quality Assurance preferably in the pharmaceutical, food, or nutritional industry + Good knowledge of GMP, GDP and HACCP are preferable + Strong communication and interpersonal skills, good command of both written and spoken English and Chinese + Good computer literacy + Self -motivated and able to work independently + Responds quickly and being proactive An Equal Opportunity Employer Abbot welcomes and encourages diversity in our workforce. We provide reasonable accommodation to qualified individuals with disabilities. To request accommodation, please call 224-667-4913 or email corpjat@abbott.com