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聘:ValidationSupervisor

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招聘要求 | 更新时间：2022-07-28 11:23:41
职位类别：  其它类 招聘职位：  ValidationSupervisor
专业类别：  不限 专业要求：  不限
招聘对象：  在职 工作性质：  全职
工作地区：  洞泾镇 招聘人数：  1人
性别要求：  不限 有效天数：  90天
学历要求：  本科 年龄要求：  23-35岁
岗位描述：  职位信息
Responbility：
Support the development, implementation, and oversight of an effective validation process that operates in compliance with corporate validation polices and procedures, and relevant regulatory requirements and industry guidance, including:
- Establish and maintain validation process; include facility validation, equipment validation, process validation, sterilization validation ect;
- Responsible for developing and updating valdiation protocol and report template;
- Ensure compliance to Design Control Standard Practices, software validation, process validations and test method validation procedures with regards to sterility assurance processes.
- Responsible for working with supplier to maintain validation documentation and record;
- Ensures compliance to all customers, cGMP, ISO 13485 and GMP requirements.
- May also include process equipment design, development of startup documents, commissioning plans, validation/qualification documents, execution of commissioning plans, executing qualification activities, assisting maintenance,
- Provides Quality related training/education for company personnel.
- Support customer audits, including response and corrective action tracking;
Requirement:
1. Bachelor’s Degree – Life Sciences or Engineering.
2. Minimum five(5) years of experience in a validation role within a manufacturing environment, such as life sciences, food and beverage, automotive or aerospace with preferred emphasis in life sciences (e.g. pharma, biopharm, or medical device).
3.Strong knowledge of ISO 13485 and/or cGMP requirements and relevant industry standard practices is required. Must have ability to interpret these regulations to ensure proper implementation in the plant systems.
4.ASQ certifications desirable (e.g. CQE, CQM, CQA)
5.Demonstrated experience in DQ, IQ,OQ, PQ .
6.Full knowledge on Data Integrity and GDP ;
7.Must have excellent verbal and written communications skills to interact with internal and external personnel on plant processes and projects .
8.Must work well in a team environment, possess an ability to adapt to change in the environment, and have proven ability to exert influence in a directive and positive manner.
9.Proficient computer skills required including Microsoft Word, Excel, Visio, PPT, and Project
参考薪资：  20000-30000 其它待遇：  五险一金，带薪年假、年底双薪、每年加薪、
企业信息
单位名称：  上海海顺新型药用包装材料股份有限公司 [给公司发站内短信]
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