深圳招聘

岗位职责:<BR><P>1.基于质量设计、工艺条例以及企业质量要求，为静脉注射解决方案的产品设计适当的研发处理过程；<BR>2.评估提交的研发过程方案，鉴定关键的过程参数并建立一致健全的处理研发过程；<BR>3.负责转移端到端现有产品；<BR>4.对大规模研发项目进行研究分析并结合小组推荐，得出结论，运用先进的高科技技术解决难题；<BR>5.及时向管理层提出适当意见；<BR>6.独立设计、执行并管理项目；<BR>7.根据SOP书写并实施研究协议及报告；<BR>8.执行研究并支持制造厂进行检查；<BR>9.通过各种方法及渠道完美实现项目；<BR>10. 负责监督指导研究团队；<BR>13.保证遵守卫生部现有与发展中的规定（比如：SFDA、TGA、FDA等等），以及其他管理机构和企业法规政策。<BR><BR>1.Design appropriate process based on Quality by Design, Industry regulations and Company quality requirements for IV solution products;<BR>2.Evaluate and Qualify proposed process. Identify critical process parameters and establish controls for building consistent and robust process;<BR>3.Transfer existing products from site to site;<BR>4.Reach conclusions based on research analysis and incorporate recommendations into larger projects. Apply advanced techniques to solving difficult problems;<BR>5.Advise management regarding appropriate action;<BR>6.Independently plan, execute and manage projects/programs;<BR>7.Write and implement study protocols and reports. Write and implement SOP's;<BR>8.Execute studies and support inspections in manufacturing plants;<BR>9.Communicate with various functions to achieve project milestones;<BR>10.May supervise and direct Research Associates;<BR>11.Assure compliance with current and awareness of developing regulations with Boards of Health (i.e. SFDA, TGA, and FDA etc), other regulatory agencies and corporate policies;<BR>12.Fufill job responsibilities in compliance with GxPs, where applicable.<BR></P>
<BR>任职资格:<BR><P>1.至少10年相关领域工作经验的本科理学士、至少7年相关领域工作经验的理科硕士或至少4年相关领域工作经验的理科博士，药学专业背景为佳；<BR>2.必须在该领域有相关终端无菌液体产品的研发和制造经验；<BR>3.了解注射剂药品工业领域的GMP规范；<BR>4.有技术团队领导经验或管理经验者为佳；<BR>5.熟悉GMP实行以及ICH需求；<BR>6.对研发过程/系统具有扎实的理论知识，并且具备相关实验室技能、计算机技能以及一定的书写技巧；<BR>7.较强的团队协作精神、人际关系技巧以及优秀的协调组织能力；<BR>8.英语精通（书面及口语）；<BR>9.对日常特定的研究工作具备一定的工作认知；<BR>10.能够独立完成日常工作及一些日常工作决策；<BR>11.能够在项目中表现出很好的灵活性和灵动性。<BR><BR>1.Bachelor's degree in a scientific discipline with at least 10 years of relevant experience, MS with at least 7 years, or PhD with at least 4 years of relevant experience. Preferably majored in pharmaceutical sciences;<BR>2.Experiences in developing/manufacturing terminally sterilized liquid products is a big plus;<BR>3.GMP experiences in parenteral pharmaceutical industry would be a great advantage. <BR>4.Leadership of technical teams, and project management experience is desirable;<BR>5.Good understanding of GMP practice as well as ICH requirements;<BR>6.Sound knowledge in R&D process/system, relevant laboratory skills, writing skills, and computer skills;<BR>7.Strong teamwork/interpersonal skills and excellent coordination skills;<BR>8.Excellent written and oral English skill;<BR>9.Must possess working knowledge of specific scientific discipline governing day-to-day activities;<BR>10. Ability to make routine and some less routine decisions independently;<BR>11. Demonstrate flexibility and the ability to shift gears between projects comfortably. <BR></P>

Capgemini Engineering凯捷科技研发是全球工程研发 (ER&D) 服务的企业合作伙伴，基于其在数字化和软件领域的深厚行业知识及前沿技术积累，凯捷科技研发赋能客户实现数字世界和现实世界的融合，并结合集团其他部门的能力，加速其产业智能化的发展步伐。凯捷科技研发现有超过55,000名工程师和技术专家，遍布全球30多个国家，服务于航空、航天、国防、海军、汽车、铁路、基础设施与交通、能源、公用事业与化工、生命科学、通信、半导体与电子、工业与消费、软件与互联网等产业。

Capgemini Engineering是凯捷集团必不可少的一部分。凯捷是全球知名的企业合作伙伴，利用技术的力量改造和管理企业业务。其宗旨是通过技术释放人类能量，创造一个包容和可持续的未来。凯捷是一个负责任的多元化组织，在50余个国家拥有超过34万名团队成员。凭借其55余年的悠久历史和深厚的行业专业知识，在快速发展的云、数据、人工智能、互联连接、软件、数字工程和平台的创新世界推动下，凯捷深受客户信任，能够满足客户从战略、设计到运营的多方位业务需求。集团2021年全球收入为180亿欧元。