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).