生物制药QA招聘 - 德恩(广州)认证咨询有限公司
- 工作经验
- 5-7年经验
- 工作性质
- 全职
- 学历要求
- 大专以上
- 薪资待遇
- 1-1.5万/月
- 招聘人数
- 发布时间
- 2021-09-03
- 工作地点
- 苏州-工业园区
- 福利待遇
协助客户质量体系文件建立项目,与专家一同执行受委托的审计,积累、维护和改善内部文件模板。
岗位描述:协助组织和实施外部客户文件体系建立项目及管理;协助执行质量管理体系的现场审计,包括内审、第二方和第三方审计;协助建立和完善质量管理体系文件模板;参与内部质量管理体系的文件的编写、培训和维护;参与内部质量管理体系要求的其它相关活动。编写GMP相关的技术文件,执行风险评估等 ;项目谈判过程的技术支持。
任职要求:药学、生物科学、制药工程、化学等相关专业;具备药品质量和生产相关专业知识,熟悉海外和中国GMP等法规相关知识;负责质量体系工作5年及以上;良好的中英文听说读写能力。
Assist client to establish projects about the quality system documentation, perform commissioned audits, and accumulate, maintain and improve the internal document templates.
Responsibilities:
1. Assisted in the organization and implementation of external customer documentation system, project establishment and management;
2. Assist the on-site audit of the quality management system, including internal audit, second-party and third-party audit;;
3. Assist in the establishment and improvement of the quality management system document templates;
4. Participate in the preparation, training and maintenance of documents for the internal quality management system;
5. Participate in other related activities required by the internal quality management system;
6. Prepare GMP-related technical documents, perform risk assessments, etc;
7. Technical support for the project negotiation process.
Qualification:
1. Graduated in related fields such as pharmacy, pharmaceutical engineering, chemistry and biotechnology;
2. Professional knowledge of pharmaceutical quality and production, and be familiar with relevant knowledge of overseas and Chinese GMP regulations;
3. More than 5 years experiences in the quality system;
4. Good spoken and written skills in both Chinese and English.
岗位描述:协助组织和实施外部客户文件体系建立项目及管理;协助执行质量管理体系的现场审计,包括内审、第二方和第三方审计;协助建立和完善质量管理体系文件模板;参与内部质量管理体系的文件的编写、培训和维护;参与内部质量管理体系要求的其它相关活动。编写GMP相关的技术文件,执行风险评估等 ;项目谈判过程的技术支持。
任职要求:药学、生物科学、制药工程、化学等相关专业;具备药品质量和生产相关专业知识,熟悉海外和中国GMP等法规相关知识;负责质量体系工作5年及以上;良好的中英文听说读写能力。
Assist client to establish projects about the quality system documentation, perform commissioned audits, and accumulate, maintain and improve the internal document templates.
Responsibilities:
1. Assisted in the organization and implementation of external customer documentation system, project establishment and management;
2. Assist the on-site audit of the quality management system, including internal audit, second-party and third-party audit;;
3. Assist in the establishment and improvement of the quality management system document templates;
4. Participate in the preparation, training and maintenance of documents for the internal quality management system;
5. Participate in other related activities required by the internal quality management system;
6. Prepare GMP-related technical documents, perform risk assessments, etc;
7. Technical support for the project negotiation process.
Qualification:
1. Graduated in related fields such as pharmacy, pharmaceutical engineering, chemistry and biotechnology;
2. Professional knowledge of pharmaceutical quality and production, and be familiar with relevant knowledge of overseas and Chinese GMP regulations;
3. More than 5 years experiences in the quality system;
4. Good spoken and written skills in both Chinese and English.
最新招聘
- GMP专员 月薪: 工作性质: 发布时间:2022-02-16
- CSV工程师 验证工程师 月薪:1-1.2万/月 工作性质:全职 发布时间:2021-09-04
- 生物制药QA 月薪:1-1.5万/月 工作性质:全职 发布时间:2021-09-03
- GMP质量管理工程师-QA方向 月薪:0.8-1.2万/月 工作性质:全职 发布时间:2021-06-17
- 商务专员 月薪:4-8千/月 工作性质:全职 发布时间:2021-06-06
- QA工程师 月薪:1-1.5万/月 工作性质:全职 发布时间:2021-05-28
- 验证工程师 CSV工程师 月薪:0.8-1.2万/月 工作性质:全职 发布时间:2021-05-28
联系方式
- 地址:广东省广州市天河区华明路9号华普广场西塔1411室
- 邮编:510623
- 电话:020-8736 0156
- 联系人:未提供
- Email:gempexchina@126.com
产品分类
站内搜索