上海招聘

岗位描述 

1. 协助建立和完善专业的计算机系统验证和管理体系；

2. 协同专家实施计算机化系统首次验证和再验证项目；

3. 根据项目需求协助编写计算机化系统验证计划及验证方案、现场执行验证、编写报告；

4. 协同专家完成计算机系统相关SOP内容的制定和完善，确保符合行业法规；

5. 参与CSV相关的内外审计；

任职要求

1. 计算机，自动化，软件工、医药等相关专业本科以上学历；

2. 2-3年制药企业质量、工程或IT部门的相关工作经验，熟悉GMP环境下工作的基本要求；

3. 有计算机系统验证的实战经验，拥有以下一种或多种验证经验优先，如SAP，LIMS,WNS等；

4. 熟悉GMP法规，GAMP5对计算机系统验证和电子数据的要求，并能根据法规要求进行验证和维护数据库安全运行与故障处理，资源优化和容量规划能力 ；

5. 英语能力良好，尤其能熟练阅读和书写英语文件，口语较好者优先。

Reponsibilities:

1. Establishing and improving the csv and the management system to ensure the compliance of the computer system;
2. Guiding the client the projects of computerized system validation and revalidation validation confirmation, organizing the establishment of computerized system validation plan to facilitate validation, and reviewing the validation scheme and conclusions for compliance;
3. Organize and guide customers to complete the formulation and improvement of computer system content in SOP, and continuously promote the continuous improvement of GMP management system;
4. Responsible for coordinating the implementation of the computer system validation program to ensure compliance with GMP related automated and/or csv;
5. Responsible for the establishment of management procedures for csv;
6. Participate the csv-related audits;
7. Offer the csv-related trainnings;

                            

    

Qualifications:

    

1. Bachelor degree or above in computer, automation, software engineering, medicine or related field;
2. 2-3 years related working experiences in pharmaceutical quality, engineering or IT department, familiar with basic requirements in GMP environment;
3. Practical experiences in computer system verification, one or more of the following verification experiences is preferred, such as SAP,LIMS,WNS, etc;
4. Familiar with GMP regulations, GAMP5 requirements on computer system verification and electronic data, and able to verify and preserve database safe operation fault handling, resource optimization with capacity planning according to regulations;
5. Good command of English, especially good at reading and writing English documents, oral English is preferred.

                

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