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Position Process Technologist
Company Info An European Company
Responsibilities Job Purpose 岗位目的:


Ownership of processes in the manufacturing and packaging facilities including process capability, process improvement initiative, process problems ownership and trouble-shooting.




Key Responsibilities主要岗位职责:




Prioritize work efforts to meet goals.


Taking ownership for the manufacturing/packing process on site to ensure process capability is achieved which including product quality trending, ownership of processing problems and trouble-shooting.


Enhance the Process understanding for the manufacturing and packaging processing which include process robustness study, initiate process improvement, and carry out trial and process validation.


Lead project to improve line performance.


Lead investigation and trouble shooting for issues, deviations/incident, customer complaint and failures, and evaluate the effectiveness of corrective actions to ensure no recurrence.


Draft, review and execute related validation documentation related to manufacturing and packaging process. (URS, PIP, IQ, OQ, PQ etc .)


Provide technical input for Change control evaluation and initiation.


Provide support for the Annual Product Review and understand the process capability and implement improvement plan.


Provide routine support for the site in term of QMS implementation, updating of relevant SOP/BOM/PPI/Batch record, response to regulatory or customer request.


Establish, maintain and develop good relationships with other departments and make the communication smooth and effective.


Perform other jobs assigned by Process Section Manager.
Requirements Specialized Knowledge 专业知识:


Bachelor or above education in engineering, science or pharmaceutical or related background.


At least 3 years experience in pharmaceutical manufacturing environment


Good process understanding knowledge and good analytical skills.


Good knowledge and understanding of GMP requirement


Knowledge and understanding of complex manufacturing and packaging processes


Standards of hygiene, quality, housekeeping required


Controlling of documentation.


Good communication and interpersonal skill, Good leadership


Good English level including oral communication, writing and listening


Good computer skills
Update 2014-09-26
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