Senior QA Engineer高级QA工程师
欧璧医药包装科技（中国）有限公司
- 公司规模：150-500人
- 公司性质：外资(欧美)
- 公司行业：医疗设备/器械
职位信息
- 发布日期：2016-10-17
- 工作地点：张家港
- 招聘人数：1人
- 工作经验：5-7年经验
- 学历要求：本科
- 语言要求：英语 熟练
- 职位月薪：8000-9999/月
- 职位类别：质量管理/测试工程师(QA/QC工程师)
职位描述
职位描述：
1.Quality System-Provide guide in Quality Assurance / GMP / ISO 15378 / ISO9001 related topics, drive the continual improvement.
-Implement local quality system according to corporate quality system requirement. Conduct monitoring and trend analysis for Quality System Implementation.
2.Documents:-Maintenance site GMP related documentation under guide of line manager.
-Review batch record.
3.Certificates:Prepare the CoA for customers on time.
4.Complaint Handling:Assist QA manager to investigate the root cause, data and evidence collection
5.Qualification and Validation:Qualification and Validation activities set up and coordination for implementation.
6.Audit:Prepare and involve customer / 3rd party / Internal Audit
7.CAPA / Change Control:Manage CAPA, Change Control with Pragma
8.Supplier Management:Monitor supplier performance, handle supplier quality issue, perform supplier audit.
9.Training:-Perform training courses arranged by HR department;
-Train QA engineer/assistant;
10.Others:Other job assigned by QA manager.
Qualification:
1.Prefer experiences in Pharmaceutical Packaging, medical device, Food industry or other related filed.
2.Excellent problem solving skills, Systematic thinking, Result Oriented, Process Approach.
3.High sense of responsibility, good teamwork and cross functional communication.
4.More than 5 years working experience in quality department, experience in GMP/ISO implementation and continual improvement.
5.Good spoken and written English.
6.Integrity, Trust and respect everyone, Be accountable, Be ethical, always, Listen and communicate with transparency and honesty.
举报
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1.Quality System-Provide guide in Quality Assurance / GMP / ISO 15378 / ISO9001 related topics, drive the continual improvement.
-Implement local quality system according to corporate quality system requirement. Conduct monitoring and trend analysis for Quality System Implementation.
2.Documents:-Maintenance site GMP related documentation under guide of line manager.
-Review batch record.
3.Certificates:Prepare the CoA for customers on time.
4.Complaint Handling:Assist QA manager to investigate the root cause, data and evidence collection
5.Qualification and Validation:Qualification and Validation activities set up and coordination for implementation.
6.Audit:Prepare and involve customer / 3rd party / Internal Audit
7.CAPA / Change Control:Manage CAPA, Change Control with Pragma
8.Supplier Management:Monitor supplier performance, handle supplier quality issue, perform supplier audit.
9.Training:-Perform training courses arranged by HR department;
-Train QA engineer/assistant;
10.Others:Other job assigned by QA manager.
Qualification:
1.Prefer experiences in Pharmaceutical Packaging, medical device, Food industry or other related filed.
2.Excellent problem solving skills, Systematic thinking, Result Oriented, Process Approach.
3.High sense of responsibility, good teamwork and cross functional communication.
4.More than 5 years working experience in quality department, experience in GMP/ISO implementation and continual improvement.
5.Good spoken and written English.
6.Integrity, Trust and respect everyone, Be accountable, Be ethical, always, Listen and communicate with transparency and honesty.
职能类别： 质量管理/测试工程师(QA/QC工程师)
公司介绍
欧璧医药包装科技（中国）有限公司是意大利斯蒂瓦纳托集团在亚洲的第一个全资子公司，该项目占地45亩，总投资3亿欧元，其中一期总投资5000万欧元，注册资本4000万欧元，拟引进世界最先进的自动化设备，生产高标准无菌医药包装材料，一期项目年产西林瓶、卡式瓶4.5亿只，达产后年销售超5000万欧元。
欧璧医药包装科技（中国）有限公司的母公司意大利斯蒂瓦纳托集团成立于1949年，主要从事粉针、水针用西林瓶等药包材玻璃制品及自动化设备的生产制造，是世界上最大的医药包装自动化设备制造商之一，也是全球三大玻璃制品制造巨头之一，在世界高端医疗包装行业中占据着举足轻重的地位。
公司网址：www.stevanatogroup.com
欧璧医药包装科技（中国）有限公司的母公司意大利斯蒂瓦纳托集团成立于1949年，主要从事粉针、水针用西林瓶等药包材玻璃制品及自动化设备的生产制造，是世界上最大的医药包装自动化设备制造商之一，也是全球三大玻璃制品制造巨头之一，在世界高端医疗包装行业中占据着举足轻重的地位。
公司网址：www.stevanatogroup.com