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南通外资原料药工厂，招聘
质量部经理:qa,qc,compliance
主要责任
Key responsibilities, compliance head
• 准备并审核所有将提交中国当局的文件
Prepares and reviews all documents to be submitted to the Chinese authorities
• 组织GMP相关审计（内部或外部）
Organize the GMP audit (internal or external)
• 保持高效的和有效的质量体系
Keep efficiency and effective QA system
• 与总部协调改善质量体系
Coordinate with HQ to improve QA system
• 对客户的投诉进行调查并进行纠正预防措施
Response for customer complaint investigation and CAPA implementation
• 组织GMP相关的培训
Organize GMP related training
• 新产品的GMP申请
New products application of GMP
• 定时举行质量会议
Perform a regular quality meeting
• 向总部汇报技术报告
Technical report to headquarter
• 确保原辅料、包装材料、中间产品、待包装产品和成品符合经注册批准的要求和质量标准
To ensure that all starting materials, packaging materials, intermediate, bulk and finished products meet the registration requirements and specifications
• 确保在产品放行前完成对批记录的审核
To ensure that the batch records are reviewed before product release
• 确保完成所有必要的检验
To ensure that all necessary testing is carried out
• 批准质量标准、取样方法、检验方法和其他质量管理的操作规程
Approve specifications, sampling methods, testing methods and other quality management procedures
• 审核和批准所有与质量有关的变更
Review and approve all quality related changes
• 确保所有重大偏差和检验结果超标已经过调查并得到及时处理
To ensure all significant deviations and out-of-specification results are timely investigated and handled
• 批准并监督委托检验
Technical approve and monitor any contract analysis
• 监督厂房和设备的维护，以保持其良好的运行状态
Check the maintenance of premises and equipment for the purpose of maintaining a sound operating state
• 确保完成各种必要的确认或验证工作，审核和批准确认或验证方案和报告
Ensure the necessary qualifications or validations are done appropriately, and to review and approve validation protocols and reports
• 确保完成自检
Ensure self-inspection is done
• 评估和批准物料供应商
Assess and approve material suppliers
• 确保所有与产品质量有关的投诉已经过调查，并得到及时、正确的处理
Ensure all quality related complaints are timely and properly investigated and handled
• 确保完成产品的持续稳定性考察计划，提供稳定性考察的数据
Ensure the implementation of on-going stability study and make the stability data available
• 确保完成产品质量回顾分析
Ensure that the product quality reviews are done
• 确保质量控制和质量保证人员都已经过必要的上岗前培训和继续培训，并根据实际需要调整培训内容
To ensure that the necessary initial and continuing training of personnel in Quality Control and Quality Assurance is carried out and adapted according to need
• 执行主管的其他要求
Others supervisor requested
Critical Experience and Skills
summarized the most important requirements for the Head Compliance position
• At least 5 years of experience as Head Compliance / Head QA in API manufacturing industry
• Preferably experience in international companies / with international customers
• Basic knowledge on QC topics
• Very good English skills
• Experience in Chinese and US FDA Inspections
• Senior and strong personality to ensure high quality standard in collaboration with other department heads
• Convincing and self-confident personality to represent Siegfried Quality system in customer visits / audits
欢迎随时联系，薪水30-40万/年
Best Regards Kyle You│游洪凯|Wechat: youhongkai1988 Mobile: (+86) 13550289723
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发表于 2015-7-10 17:34:51
置顶卡
变色卡
这薪水是相当诱人的
等我把BEC高级考下来的再试一下，哈哈