上海招聘

工作地点：浦东新区

Conduct In-Process Quality Assurance checks during the analysis of USP Reference Standards and R&D work. Conduct In-Process Quality Assurance checks during the evaluation of USP Reference Standards and method development in the USP-China Laboratories.

Maintain USP-China quality management system. Works independently to resolve issues within the site, and assists Corporate QA in resolving more global issues. Also, conducts necessary QA training for the site.

Roles and Responsibilities:

· Conducts Quality Assurance in-process checks in the USP-China Laboratory areas as directed by appropriate Standard Operating Procedures. Ensure properly calibrated/ validated equipment is used in the evaluation of Reference Standards and analytical method validation.

· Conduct reviews of laboratory paperwork and Notebooks to ensure all testing is appropriately documented.

· Maintain Quality Management Systems such as the Deviation Reporting, CAPA, Document Control and OOS Programs. Also, assists in laboratory investigations of unexpected results.

· Leads/attends internal and external quality audits.

· Works with lab operation group to ensure the calibration/validation and preventive maintenance of equipment is performed. Ensures properly calibrated/validated equipment is used in the evaluation of Reference Standards and method validation.

· Identifies trends and problems based on data analysis, and reports and conduct actions accordingly.

· Provides quality training to site staff. Helps to determine development needs of lab analysts and assists in the training.

· Leads supplier evaluation program for critical suppliers.

· Leads/attends process improvement teams or initiatives.

Frequent Contacts:

· China QA Director

· China site staff

· Internal USP QA Departments

· Internal Cross Functional Groups

Minimum Requirements:

·A bachelor’s degree and above (Master degree preferred) with at least 5 years of responsible quality management experience.

KSAs and Training and Experience:

·Working knowledge of MS Word, Excel and Access are required.

·Excellent problem solving technical writing and auditing skills are required.

·Candidate must understand GMP, GLP, and ISO regulations and the integration of the regulations into working systems in the laboratories and site.

·Fluent written/speaking English.

·Excellent communication Skills

Supervisory Requirements:

QA Specialist

除美国之外，USP标准和标准品在的世界上其他130多个国家也得到广泛的使用。建立185年以来，这些标准一直服务于世界各地，确保公众获得优质的药品。
鉴于中国和亚太地区其他国家的战略重要性，USP在上海张江高科技园区设立了中华区总部，并建成了USP在全球的第三个标准品研发中心实验室。现公开招聘所述职位，诚邀您的加盟。
应聘者请将中英文简历、近照、应聘职位和期望薪资发送给我们。
欲了解USP更多详情，欢迎访问我们的网站。
请将中英文简历发至所述邮箱: uspchinahr@usp.org

The United States Pharmacopoeia(USP)is the official standards-setting authority for all prescription and over-the-counter medicines, dietary supplements, and other healthcare products manufactured and sold in the United States.USP is also a world leader and its reference standards are recognized and used in many other countries outside the United States. These standards have been helping to ensure good pharmaceutical care for people throughout the world for more than 185 years.
For more details about USP, please visit our website.
Attaching great importance to China and Asian Pacific countries, USP is setting up its regional headquarter in Shanghai located in Zhang Jiang Hi-Tech Park.
Currently we are looking for the positions for USP-China.Please indicate the position that you are interested and send us your resume and salary expectation to us.
Please send your bilingual resume to us
请将中英文简历发至所述邮箱: uspchinahr@usp.org