Job summary
Job category | Technical (Sales / Design / Development / Production Control)/Production Control / Quality Control / Construction Control / Environment, Health, and Safety / Postmarketing Surveillance |
---|---|
Industry | Health Care/ Other Health Care |
Employment type | Uncategorized |
Position level | Director or Above |
Number of openings | 1 |
Desired entry time | - |
Required language skill | |
Foreign language competence | - |
Working hours | Others |
Welfares / Leave systems |
Work details
Multinational Company
Exposure to work with global partners
Opportunities to work with the dynamic team
Our Client is a multi-national company with global presence within the Pharmaceutical industry. They are seeking a QA Head responsible for all Quality activities in the pharmaceutical plant in China.
You are responsible for setting quality policy, objectives, and the development and maintenance of the Quality Management Systems. The incumbent will also manage the QA group to maintain quality systems, on-going manufacturing activities and provide quality support to internal and external customers. Role is required to communicate with Chinese speaking stakeholders.
Ideally you should have a minimum Degree in Science field with minimum 10 years in pharmaceuticals, as well as minimum 5 years of Quality experiences and track record of managing regulatory inspections. Expertise in clinical and commercial drug regulations, and working knowledge of product development and clinical manufacturing requirements. In-depth technical and regulatory understanding of cGMP drug substance pharmaceutical manufacturing, as well as applicable international regulations (FDA, EMEA, TGA) and standards (USP, ICH) in all phases of clinical and commercial manufacturing. Solid understanding of CMC regulatory requirements for drug substance in various stages of development, as well as practical application of principles of QbD. A thorough understanding of regulatory agency inspection requirements (USFDA, EMA, TGA) is required.
Willing to relocate to China.
About interview
Liaison
QA Head, China
RGF HR Agent
Negotiable / Unpublished