验证经理
职位编号 C06140080
行业 制药/医疗
类型 医疗设备/器械
所在地 重庆
职位描述:

1、Assure that all areas of Plant facility comply with current Good Manufacturing Practices;
2、Define and implement Quality Validation objectives and strategies, participates with other managers to establish company policies;
3、Supervise and direct the development and administration of budgets, schedules resources allocation;
4、Review & approve documents related to validation, organize and coordinate the carrying out of activities related to validation, assure the establishing of validation system, and function effectively;
5、Assure that validation master plan and other validation activities are performed in full compliance with FDA regulations, current Good Manufacturing Practices (GMP), and SOPs.

职位要求:

1、Have systematic/strong knowledge of GMP and validation management;
2、Have the ability of analysis, handling and solving the problem in the daily validation work;
3、Have strong learning ability, acquire the knowledge of the GMP management;
4、Have strong ability of logical thinking, and be good at communication and coordination;
5、Requires a B.S.(or above)degree in pharmaceutical or related;
6、5 years management experience in Validation (participateIing with the qualification of FDA and GMP is a plus), QA or similar function within a pharmaceutical environment. (Substantial pharmaceutical engineering experience will be a plus).

 

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