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Quality Control Manager for Changsha COE laboratory
知名企业

职位年薪:面议
  • 所属行业:
  • 企业性质:美资
  • 招聘人数:1人
  • 工作地点:湖南长沙
  • 联 系 人:刘先生
  • 联系电话:020-38013151
  • 联系邮箱:liuying@gz-guidance.com
  • 发布时间:2013-10-24

岗位要求

  • 学历要求:
  • 性别要求:不限
  • 语言要求:
  • 年龄要求:
  • 工作年限:

任职资格描述

Skills/Education/Experience: Educations: Minimum University Degree in Pharmaceuticalor Chemistryor 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. Others: •A good team player with proven interpersonal and communication skills. •Possess good organization and planning skills, i.e. ability to organize workload and manpower in achieving the highest testing efficiency in the COE lab. •Set up the equipment and testing method validations program and has a good communications with the equipment vendor to finish IQ,OQPQ verification. 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 xxx 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 Chinagovernment. 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.
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