武汉招聘

职位描述：
Major Accountabilities主要职责

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 Sandoz/Other Novartis 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 Sandoz Global Operation Procedure GOP0504.
负责所有来自山德士/诺华事业部/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；负责与山德士/诺华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山德士集团方针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。

    
Background 背景


Education教育 : 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
Languages语言: 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。
Experience经验:
1）Be familiar with GMP, be suitably trained and ideally has more than five years of related work 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。

2）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。

3）Mastering certain computer operating.
具有一定的电脑操作水平。 举报 分享

山德士是瑞士诺华集团的子公司，诺华集团是世界第三大制药公司、世界500强企业，是全球唯一在专利药、非专利药、疫苗和非处方药业务上都拥有领导地位的制药公司。诺华集团成立于1996年，由瑞士两家具有百年历史的世界著名制药公司汽巴-嘉基与山德士合并而成。山德士主要从事非专利药品的研发、生产和销售，业务涵盖原料药、制剂和生物制品，拥有950多个化合物和5000多种制剂，是全球第二大非专利药公司。山德士（中国）2007年1月正式开展中国业务，于当年12月20日向德国格兰泰公司收购了位于中山市火炬区健康基地的中山格兰泰制药，并在中山成立了山德士(中国)制药有限公司，注册资金2200万美元，投资总额达3500万美元.