北京招聘

职位描述：
Responsibilities/ Authorities工作职责权限:
1. Working out manufacturing concept, create machine and system specification based on cGMP,
2. Lead process study, set up production parameters, create process SOPs
3. Lead production line validation and qualification
4. Coordinate supplier qualification for raw material to ensure raw material quality. Create raw material specification for Supplier Quality Agreement. Take part in raw material supplier audit.
5. Lead P-FMEA for production process, implement In Process Control System, define control criteria and specifications
6. Lead quality risk assessment of deviation or non-conformity in production line. Issue and manage process-related NCRs, lead CAPA
7. Take care of new product transfer project. Lead CCO process with different departments; create DMR (device mater record).
8. Support QM to deal with customer complaints
9. provide training to production line employee in terms of IPC and cGMP
10. Take care of Continuous Improvement Projects
11. Other Tasks based on alignment with department head
Qualifications任职资格:
Education background教育背景:
Master /bachelor of science majored in Engineering
Work experience工作经验:
At least 5 years working experience in a pharma or medical device manufacturing plant.
Manufacturing or engineering department,
Experience in highly automated production line,
Project management background,
Experience to cooperate with local and foreign machine supplier
Competence and skills技能技巧:
Strong competence in process engineering and production system
Good at CAD tools
Good skills in PC, MS office
Familiar with cGMP and ISO 13486
Familiar with Lean manufacturing: 5s, six Sigma, Value Stream Design and others
Others其它:
Very good English in speaking and writing, German skills will facilitate your work a lot.
Target-oriented working, creative thinking, very communicative 举报 分享

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