上海招聘

Job Description

Reports to: QA Manager, China

职能类别：生物医药行业

职位描述：

工作经验：需要有化学分析实验室及生物实验室的QA工作经验。

Function of the Position:

Conduct In-Process Quality Assurance checks during the analysis and evaluation of USP Reference Standards, Verification samples and analysis method development in the USP China Chemical Laboratories, Biologics and Biotech Laboratories.

Maintain and improve the quality management system and lab management system at USP China.

Works with China QA team to resolve issues within the site, and assists Corporate QA in resolving global issues.

Roles and Responsibilities:

Conducts reviews of laboratory paperwork and report to ensure all testing is appropriately documented and reported.

Issues Laboratory Notebooks and maintains lot numbering database

Conducts Facility inspection and method inspection in USP China labs to ensure the labs operate following ISO standards and USP SOPs and perform test following methods

Attends internal process audit and external audit of ISO 9001 and ISO 17025

Assists in investigations of unexpected results and deviation, and follow up the actions

Supports Quality Management Systems such as the Deviation, Lab investigation, CAPA and Document Control.

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

Conducts training to USP China staff on quality standards and topics.

Works as a team member for process improvement or initiatives and assisting in all other day-to-day QA activities.

Frequent Contacts:

China QA Team

China Lab staff

China Lab operation teams

Internal USP Departments

Internal Cross Functional Groups

Minimum Requirements:

A Master’s degree majored on biologics and biotechnology, or related science and technology, with at least 3 years of QA experience in pharmaceutical/biotech type industry, it is preferable to additionally have experience in laboratory of pharmaceutical/biotech type industry for at least 2 years.

KSAs and Training and Experience:

Working knowledge of MS Word, Excel and PowerPoint are required.

Good problem solving skills are required

Good technical writing and auditing skills are required.

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

Excellent communication Skill

Ability to write/speak English/mandarin fluently

Teamwork and result driving

Supervisory Requirements:

None

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