Process Technologist __天津市源创企业管理咨询有限公司

猎头职位

职位名称	Process Technologist
公司信息	外资制药企业
职位描述	Process Ownership Taking ownership for the manufacturing 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 processing which include process robustness study, initiate process improvement, carry out trial and process validation. Define critical process parameters and implement standardization and control in the manufacturing process Provide technical input for Change control evaluation and initiation, including raw material changes Provide support for the Annual Product Review and understand the process capability and implement improvement plan. Support the GMS Technology strategy including implementation of PAT to improve the process control or enhance the process understanding Provide routine support for the site in term of QMS implementation, updating of relevant SOP, response to regulatory or customer request. Products Transfer and Capital projects Taking ownership for the processes associated with product transfers, providing Process Introduction, Qualification and Validation data to meet timelines. Liasing with donating sites or TSK&F R&D to obtain processing instructions, validation documentation for both product and cleaning validation analysis. Carry out process comparison assessment, plant fit and reviewing of processes, material specifications and registration details. Support the standard product transfer according to blue-print, within GMS China, from RPS/NPGS sites or from TSK&F R&D. Support the Capital project for facilities and equipment, e.g. design, sourcing of equipment, commissioning and validation (OQ/PQ). Manage the product transfer activities to ensure manufacturing and packaging processes are transferred in accordance with cGMP/QMS/CAP/SAP requirements Preparation of project documentation including URS, technology transfer documentation, qualification and validation documentation including protocols, batch records, SOP and commissioning or qualification documentation
职位要求	Specialised 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

【English】
公司地址：天津市和平区西康路72号云翔大厦18-B
电话: 022-23246796 022-23246786　　 ICP备:05001777　　技术支持:速创网络(天津网站建设)
CopyRight 1998-2009 天津市源创企业管理咨询有限公司版权所有