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).