职务描述：
Job Summary:负责产品商业化项目，包括新产品/工艺技术转移，工艺优化，上市后变更及相关项目管理偏差调查，并为法规注册提供支持。
The (Sr./Principal) TS/MS Engineer – Commercialization is responsible fcommercialization project, including new product/process technology transfer, process improvements, post-approval changes corresponding project management, deviation investigation support fregulatory registration.
Job Responsibilities:
主要职责：
1、领导并管理无菌制剂新产品/技术技术转移，包括技术转移项目管理、所需产品开发研究，法规注册支持和后续上市后变更、工艺优化等业务。同时支持一线和生产运营的相关业务需求。
Lead manage new parenteral product/process tech transfer & commercialization projects, including development technical study, the required support to regulatory registration, post approval changes process improvements. Support the TS/MS primary loop operation as required.
2、根据需要，准备、审核、批准相关技术文件和提供技术支持，并熟练GMP环境中在电子系统中的执行。如：变更管理,法规注册,偏差调查,验证方案及总结报告,生产记录,规程,工艺流程文件,验证计划,和年度质量回顾。积极参与工艺团队以实现TS/MS目标和业务及质量目标。Prepare, review, approve provide technical support fpreparation of relevant technical documents, with hands‑on experience to managing the documentation under electronic systems in a GMP environment as required, such as: change controls, regulatory submissions, deviation investigations, validation protocols summary reports, processing records, procedures, PFDs, VMPs, APRs. Participate in development implementation of process functional teams in positive fashion to implement TS/MS objectives deliver on business quality objectives.
3、遵守HSE各项管理流程，履行安全生产职责要求。
Follow various HSE management procedures fulfil the work safety responsibilities.
4、完成主管安排的其它工作任务。Finish the other duties assigned by supervisor.
5、接受主管的委派。Accept delegation from supervisor.
Job Qualifications:
岗位要求：
1、三年以上无菌制剂企业GMP环境下工作经验。
Minimum three years of relevant experience in parenteral manufacturing site within a cGMP environment.
2、具备良好的分析思维、多任务管理、决策和解决问题的能力。
Good skills in analytical thinking, multi-tasking, decision-making problem-solving.
3、具备良好的系统性学习能力,项目管理,影响力和领导项目的能力。 Good skills in learning agility, project management, ability to influence lead projects.
4、具有丰富的GMP知识和注射剂制造经验。
Knowledgeable with GMP experienced in parenteral manufacturing.
5、良好的跨部门合作能力和人际沟通关系技巧。
Good collaborative skills interpersonal skills.
6、具有良好的英语沟通能力。Good strong English communication skills.
7、良好的计算机技能。Good computer skills.
8、良好的书面和口头沟通能力。Good writtenal communications.
Additional Information:
• 申请人将工作于无菌生产工厂的各个区域。
Applicant will work in various areas within the Parenteral Plant.
• 能够根据要求加班并能及时对应生产出现的问题。
Ability to work overtime as required available off shift to respond to operational issues.
• 适当数量的出差。
Reasonable amounts of travel will be required.
More
