广州招聘

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:

1. 协助组织和实施外部客户文件体系建立项目及管理；
2. 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；
3. 协助建立和完善质量管理体系文件模板；
4. 参与内部质量管理体系的文件的编写、培训和维护；
5. 参与内部质量管理体系要求的其它相关活动。
6. 编写GMP相关的技术文件，执行风险评估等 ；
7. 项目谈判过程的技术支持。

任职要求:

1. 药学、生物科学、制药工程、化学等相关专业；
2. 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；
3. 负责质量体系工作4年及以上；
4. 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 4 years experiences in the quality system;

4. Good spoken and written skills in both Chinese and English.

加入德恩，预见更好的人生！Meet The Better You in gempex!

预见我们Foresee Us
德恩是一家独立的、全球化的服务供应商，专注于为生命科学行业提供GMP咨询与执行服务。公司总部位于德国曼海姆，并在瑞士锡瑟而恩和中国广州、苏州设有分支。
德恩总部gempex GmbH成立于2002年，公司的客户涵盖制药、化学、生物、化妆品和医疗器械等领域的领军企业。公司专注于提供GMP符合性、确认与验证、计算机验证和GMP生产相关的咨询和项目执行服务，服务范围从初始阶段的分析和概念筹划到最终实现。
gempex GmbH is an independent, international service provider specializing in consultancy and the implementation of GMP requirements in the life science industry. Headquartered in Mannheim, Germany, gempex also has sites in Sisseln, Switzerland and Guangzhou, China.
The company was founded in 2002.Customers include leading companies in the chemical and pharmaceutical industries, biotechnology, cosmetics and medical devices. Services focus on consultancy and project implementation for GMP compliance, commissioning & qualification, IT validation and GMP routines. The range of services extends from the initial analysis and concept development to their final realization.

预见机遇Foresee Your Career
我们欢迎充满激情、专业、着眼于客户、注重细节、并愿意为德恩以及客户创造价值的人才加入我们的团队：
We invite you to bring your passion, expertise and customer-oriented sense and explore career opportunities in your field of interest to your success at gempex.
What we are looking for:
-高级GMP 顾问 Sr. GMP Consultant
-GMP顾问 GMP Consultant
- GMP专家 GMP Expert
- GMP专员 GMP Specialist

预见未来的你Foresee Your Life@gempex
加入德恩，成为我们的一员。在这里，大家虽然个性不同，但拥有为实现目标而不懈努力的激情，系统培训与个性发展是您将在德恩的重要收获。我们竭诚为我们的员工提供富有竞争力的薪酬福利、绩效激励以及职业发展。我们为您提供：
五险一金 商业保险 11天带薪年假 年终奖金 年度体检 年度旅游 节日福利 员工活动 不定期下午茶 免费午餐
Join gempex, we are an inclusive highlighted by respect, collaboration, open and honest communication and diverse culture. We offer long-term adventure, daily reward, training and opportunity to carve out a unique and vibrant career.

联系我们Contact us:
企业网址Website：******
企业公众号 WeChat：gempexChina
招聘公众号 WeChat：gempex_China