转移负责工艺

【最新职位】Technical Transfer Lead/产品转移经理

【要求】主要负责固体制剂产品从国外转移到国内的项目管理。【招聘人数】2人【地点】北京或广东【岗位职责】1.P...

【要求】主要负责固体制剂产品从国外转移到国内的项目管理。

【招聘人数】2人【地点】北京或广东

【岗位职责】

1.Product Transfer and development

产品转移和研发

1）Organization of product transfer and communication with transferring site

产品转移组织以及与转移方沟通。

Responsible for receiving organization of product transfer from **Other** BU/3rd party company, including timely involvement of all relevant functions, such as production, logistics/supply chain, engineering, sourcing, finance, QA/QC, HSE, regulatory affairs; establish appropriate team roles and responsibilities for activities at the site they represent, timely exchange of information, planning, supervising, monitoring, and completion of all activities, establishment of technology acceptance criteria and closing criteria by the transfer team of TS; and the close communications with MPT Manager/responsible person in 3rd party company for the respective MPT. Responsible for ensuring all the product transfer to be organized and carried out according to ** Global Operation Procedure GOP0504.

负责所有来自**/**事业部/第三方公司的产品转移的组织接收，包括：负责适时组织所有相关部门，如生产、物流/供应链、工程、采购、财务、QA/QC、HSE、注册等；负责确定各部门在产品转移中的相应角色与职责；负责及时的信息交换；负责计划、管理、监督和执行所有产品转移相关活动；负责建立满足转移方规定的技术接受标准和产品转移关闭标准；负责与**/**事业部的各转移产品的生产工艺转移经理、以及第三方转移的生产工艺转移负责人的紧密沟通。负责保证所有产品转移严格遵照**集团方针GOP0504组织和进行。

2）Organization of Formulation study and process development

处方研究、工艺改进。

Responsible for formulation study and process development, including formulation selection, process trial and development on transferred process, and design of trial program.

负责组织新药处方、工艺研究，包括处方筛选、试制工艺摸索及转移工艺的改进，试验方案的设计准备等工作。

3）Management on Equipment Qualification in Development Workshop and Process Validation for New Products

研发车间设备确认和新产品工艺验证管理。

Responsible for organizing, management and coordination of the related validations and qualifications, and responsible for organizing of the validation/qualifications protocols drafting and relevant documents drafting, and supervising the implement of the validations/qualifications, and the evaluation of the validations/qualifications.

负责组织、管理和协调相关验证及设备确认工作，并负责组织起草验证/确认方案及相关文件，管理并监督验证/确认的执行，并进行验证评估。

4）Samples preparation and sending

样品准备及发送。

Responsible for preparing the samples for the purpose of drug research, pharmacological research, and stability studies and clinical research, and the batches for production permit application. Responsible for the related samples sending.

负责新产品转移所需药学研究、药理研究用样品、稳定性研究用样品、临床研究用样品的试制及报产批次产品的试制工作。负责上述样品的对外发送。

5）Preparation of process technical info. of submission dossiers

注册资料内工艺技术信息的准备。

6.MS&T Development Lab Management

研发实验室管理。

7.To support other MS&T activities whenever required, which includes validation,product stewardship and technology stewardship.

在有需要时，支持MS&T部门其他工作，例如验证，产品工艺管理以及技术管理。

【任职要求】

1.Achieved education level of University or above of pharmaceutical/medical professional.

必须药学或相关专业本科以上的学历。

2.Can read professional English file fluently. Fluent Oral and Written English.

能流利阅读本专业的外语参考资料。流利英语口语和英文写作。

3.Be familiar with GMP, be suitably trained and ideally has more than five years of relatedwork experience.

精通GMP条款，经过培训且有五年以上相关工作经验者优先。

4.Be familiar with characteristics of pharmaceutical materials, requirements for the dossier and operating procedure of the facilities need for new drug development and transfer and also plenty of knowledge of theory and experiences of practical operating and organizational management, could justice and handle problems correctly during new drug development and transfer.

熟悉新药研究资料的要求，熟悉药物制剂技术和制剂辅料性质，熟悉制剂设备的操作，掌握药品检验知识，具有较强的理论知识和组织管理经验，有能力对新药开发和新药转移过程中的实际问题做出正确的判断和处理。

5.Mastering certain computer operating.具有一定的电脑操作水平。

【待遇】面议

欢迎符合职位条件的人选自荐或推荐

联系人：Felix Zhang

联系电话：18915635088

电子邮箱：tonghe026@cs-job.com

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