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COE Manager
公司行业:生物/制药/医疗器械
发布日期:2014-02-25工作地点:长沙招聘人数:1
学  历:本科 及以上外语能力: 英语 流利   
工作年限: 5年以上 薪酬范围:   
职位描述:

DETAILED RESPONSIBILITIES/DUTIES:
1.Establish necessary Standard Operating Procedures (SOP) and Company policies in managing the overall COE laboratory of the Company. Prepare training program for employees of COE lab.
2.Manage the overall documentation control system for the COE laboratory and set up the LIMS system. Approve, release and revision control all SOP’s, testing procedures, raw material and finished product specifications for global products.
3.Establish and develop global testing methods for raw materials and finished goods. And perform the testing method validation according to USP and China regulatory requirement. Support the global license for new products registration in testing method side. Set up the stability program to support shelf life of finished goods.
4.Responsible for all equipment qualification and validation program. Finish IQ, OQ and PQ verification for all of laboratory equipments. Responsible for all equipment annual calibration and maintenance program according to US cGMP and China regulatory policy.
5.Work with sourcing, purchasing department to get the right new equipment and serves. Responsible for confirming parameters to buy some equipment, reagents, spare parts and so on. 
6.Assist each functional department for the setting up of measurable performance indicators. Identify key control parameters and through use of statistical technique, to run an effective in-house continuous improvement program.
7.Manage the COE laboratory and finish all of tasks within timeline. Work with HO, APAC, other Herbalife factory and OEM factory to finish all of testing.  Finish the OOS investigation reports and CAPA program for lab testing.
8.Interact with and maintain good relationships with all levels throughout the company, with auditors and customers, government authorities & officers, suppliers and vendors.
9.Check laboratory safety including equipment, reagents, waste materials and so on. Work with EHS department to ensure lab safety and meet safety requirement of China government.
10.Manage all expenses related to testing supplies and spares in meeting its annual budget and formulate plan in improving testing lab efficiency and in reducing its testing expenses.

QUALIFICATIONS:
Educations: Minimum University Degree in Pharmaceutical or Chemistry or microbiology.
English Skills: Fluent in written and oral English
Special Skills: cGMP,  GLP , Validation, Lab safety etc.
Working Experience: At least 5 years working experience in a pharmaceutical lab or research institute lab or health food lab with 3 years in a management position of a Foreign/ JV Company.

 

公司简介:
联 系 人:
电子邮箱: hr@100cheer.cn
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