职位信息

招贤纳士

职位信息

Manufacturing SME

立即申请

Dec. 03, 2020

Manufacturing SME

中国

Leverkusen

工作职责：

Provide expertise in writing/reviewing SOPs, Batch Records, Deviations, and other technical documents as it relates to the Fill Finish Operation.
Comply with GMP regulations by strict adherence to departmental policies and procedures and timely accurate completion of records as needed.
Support the management and development of improved and new processing techniques in the various aseptic processing activities.
Provide technical support to production staff involved in the various aseptic processes
Troubleshooting and technical support into process investigations
Facilitate deviation initiation , be responsible to investigate the issue, propose and execute CAPA
Facilitate/responsible of the change control process.
Work effectively with QA/QC, manufacturing, facilities and other support staff personnel
Support or lead Tech transfer projects from receiving site.
Perform process mapping and process efficiency trending
Provide the aseptic/process training to floor operation personnel
Control and manage the production GMP materials planning and logistics
Initiate and implement the process improvement projects to improve the filling efficiency and reduce the cost
Support validation and engineering project as production final user

任职能力：

Minimum of 5 years’ experience in an open aseptic cGMP pharmaceutical or medical device commercial manufacturing environment in Supervisor or Lead role
In-depth knowledge of principles governing aseptic processing systems
Knowledge of FDA regulations governing aseptic
Experience in trouble-shooting equipment and process problems in aseptic operations
Experience in aseptic operation with isolator technology

其他要求:

Are you interested in becoming part of this culture and actively shaping the future of WuXi Biologics?

Then we look forward to receiving your application documents (CV in German and English), stating your salary expectations and the earliest possible starting date.

Please send your application by e-mail to: Recruiting_Germany@wuxibiologics.com

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