工艺改进经理(制药)

Job Description

职位描述:

1. 审查和分析生产流程,对有待改良的生产工艺进行优化;
Reviewing and analyzing the production processes, optimizing the current production processes;
2. 寻找新的技术和方法应用于生产改进;
Find tools and methodology to optimize the processes;
3. 通过与不同的供应商合作,引进新的技术、工具、设备等用于改进生产工艺;
Finding new technologies for production optimization by working with different suppliers and setting up the trials;
4. 组织相关人员应用分析方法来解决工艺流程中出现的问题;
Applying methodology to solve problems in processes;
5. 与XXX生物(全球)工艺优化团队协同工作;
Works with the network of Process Optimization Team of the different XXX biological (worldwide) sites;
6. 积极促进团队工作,并加强QA,QC和生产班组之间的关系;
Promote actively team work and reinforce relationship between QA、QC and production groups;
7. 确保过程符合GMP,HSE规则和法规;
Ensure processes are compliant with GMP, the HSE rules and regulations;
8. 参与培训、标准流程的撰写、安全评估、合同谈判的前期工作;
Involved in Training, Standard Operating Procedure Writing, Safety Assessments, and Preliminary Contract Negotiations.
9. 参与新项目建设的设计和审批;
Participate with managers in the design and approval of new construction projects.
10. 审核禽飞项目确认总体规划并批准协议;
To review Qin Fei Project Validation Master Plan and approve the protocols.
11. 组织和管理ETL,QAPM和项目总监所需的项目完成,关闭和交接工作;
Organize and manage with ETL, QAPM, and Project Director all needed actions for Project completion, closure and handover.
12. 对项目客户人力资源的任何问题进行预测和解决(新岗位、培训等);
Anticipate and solve any issue regarding the project client human resources (new positions, training …).
13. 团队与生产线管理人员达成协议,并确保所有成员共享;
Assemble the team with line manager agreements and ensure that objectives are shared by all members.
14. 与项目总监制定和整合项目章程;
Prepare and consolidate project charter with Project Director.
15. 向指导委员会汇报;
Contribute to the report to the Steering Committee.
16. 与管理者进行预测和更新福利,并按时输入及交付,预算协议最终产品;
Forecast and update benefits with controller input and deliver on time, on budget the agreed end products.
17. 费用(OPEX)的跟踪;
Expenses (OPEX) follow-up.
18. 熟悉和应用所有华都XXX在健康,安全和环境中的法规和政策。
Be familiar with and apply all XXX Huadu regulations and policies on Health, Safety and Environment.

Authority
岗位权限 Supervised by
所受监督
项目总监/副总经理/XXX全球工艺改进总监
Project Director/ Deputy General Manager/ Director GIPID XXX global
Supervising to
所施监督 Client Project Team
客户项目团队
Relationships
岗位关系 Internal contact
内部联系 Project team, and all departments
项目组和各部门
External contact
外部联系 Engineering company, Design institutes, venders, sub-contractors; China Institute of veterinary drugs control, Experimental Animal Management Office, Health Supervision Institute, Academy of Agriculture, Bureau of Agriculture, Ministry of Agriculture; contact with corporate.
工程公司、设计院、供应商、分包商;中国兽医药品监察所、实验动物管理办公室、卫生监督所、省农业科学院,农业局,农业部;联系企业;

Job
Requirements
岗位要求 1. 动物医学或生物工程专业硕士及以上学历;
Post-graduate degree in biological science or bioprocess engineering; PhD is preferred;
2. 从事动物疫苗生产或相关行业(化药,生物技术),有5年以上工作经验;
Five years of industrial experience within the biological animal health vaccine manufacturing industry or a similar industry (Pharmaceuticals, Biotechnologies…);
3. 至少4年的生物制品工艺经验,能与其它工业部门良好互动;
Minimum 4 years’ experience in biological product process. Interaction with all position levels at the site is required;
4. 熟练的英语听说读写能力;
Ability to read, write and speak English.
5. 良好的沟通能力:从团队成员中获得项目的投入,管理数据和市场信息…;
Good communication skills: manages data and shares information, gets inputs in Project from Team members …
6. 良好的组织能力:规定和实现团队合作,设计工艺活动,调动资源Good organization skills: defines and implements teamwork, plans technical activities, mobilizes resources.
7. 良好的计算机技能(微软Office、Visio);
Good computer skill (Microsoft Office, Visio).
8. 自我激励:有能力去预见下一个任务;
Self-motivated. Ability to think ahead to the next task.
9. 具备多种环境下工作的能力。
Ability to work in a multifunctional environment .

 

 
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