Main Responsibilities:1. To support the Quality Manager to ensure robust quality systems are developed, implemented and maintained in adherence with Good Manufacturing Practices (GMP) of the applicable regulatory requirements (e. g. , EDQM) for the manufacturing and distribution of GMP materials to the applicable markets; 2. To deploy and maintain the core quality systems and to administer the day-to-day activities associated with CAPA, Change Control, Complaints, Supplier & Material Management, and Audit systems/ processes; 3. To act as the?competent Quality representative on Quality Compliance topics; To develop, maintain, and update applicable Quality related SOPs and documents to assure the procedures are compliant with company policies/ standards and regulatory expectations; 4. To support effective management of all internal (including Self-Inspection) and external audits; ?To track the progress and completion of all audit-CAPAs; 5. To promote and improve GMP culture?in the site; 6. To back up for material & product release and on-site QA management. Qualification:1. At least bachelor degree in Chemical, Pharmaceutical Engineering, Bio-pharma or related; 2. Minimum 5 years of direct (i. e. , hands-on) QA/ QS experience?in Pharma industry; Specific experience with non-sterile manufacturing processes (APIs, intermediates, or bulk chemicals) would be an asset; 3. Proven experience in the application and interpretation of CGMP requirements of various regulatory authorities/ guidelines (e. g. , ICH, EU, US FDA, NMPA, etc. ); 4. Detail-oriented to assure accuracy of data and information；
5. Excellent technical writing, analytical, problem-solving and communication skills; 6. Proven time management and organizational skills to work in a fast pace regulated environment; 7. Proficient in computing (e. g. , Microsoft Word, Excel, PowerPoint, Minitab, etc. ) and in performing appropriate data analysis, gap/ risk assessment; 8. Good at English communication (both oral and written skills at a professional level, capable of communicating with non-Chinese speakers independently without the need of an interpreter).
