职位描述:
Kep Responsibility:
1. Establish and maintain the quality management system to comply with relevant regulations, J&J enterprise guidance/ policies and relevant international standards such as ISO etc., Initiate appropriate actions to ensure sustainable system compliance and effectiveness.

2. Define and develop the quality system orientation and department training matrix per cross-functional quality compliance needs.


3. Ensure compliance to the standard operating procedures for partnering functions, and provide recommendation for continued improvement for process effectiveness and efficiency.

4. Lead and coordinate with x-team in QA to consolidate, develop relevant quality report and quality management review.

5. Lead and coordinate with x-department to initiate and deploy relevant quality project (ZD, NC CAPA management)and enhance quality culture/mindset by quality poster, newsletter etc.

6. The other job assignment by direct supervisor if necessary.

Key Requirement:
1. Good understanding of regulatory and other international requirements on drug, medical device and cosmetics.

2. Relevant experience and education background:
? At least 3 years experience in QA, RA or relevant area in cosmetic, Pharmaceutical, MD or OTC manufacturers.
? Previous knowledge and experience in establish and maintenance of quality system and compliance.
? Bachelor degree or above preferred on Chemistry, Pharmacy or other relevant science.

3. The other skills:
? Strong leadership, well communication & team collaboration skills, complexity/change handling, negotiation, good analytical skill/logical thinking
? Fluent English in both writing and speaking.
? Good knowledge of Computerized Software
? Good communication, collaboration and presentation skills