1.At the direction of area supervisor/department manager
在该领域主管/部门经理的领导下工作
2.Prepare, review, implement and maintain the mechanical SOPs.
起草、审核、实施和维护机械的SOP。
3.As required participate in the Weekly Operations Organization Meeting.
根据需要参加每周的运营部会议。
4. Design and draft drawings in accordance with the QMS and in supporting construction activities.
按照QMS设计和起草图纸,支持施工活动。
5. Proficient in CAD Application.
熟练掌握CAD的应用。
6. Assist with the running of GMP Clean utilities.
协助GMP清洁设备的运行。
With our cpate headquarters located in San Diego, Califnia, USA our manufacturing facility located in the scenic Heilongjiang Province in the nth eastern part of China OncoGenerix offers a fully integrated suite of services including technical transfer, process development, scale-up, equipment / process validation, fmulation, filling, lyophilization, inspection, integrity testing, labeling cartoning meeting the requirements of the US FDA, EMA, CFDA & Japan Regulaty.
公司总部位于美国加利福尼亚州圣地亚哥,生产工厂位于中国东北部风景优美的黑龙江省。基纳瑞克斯提供包括技术转移、工艺开发、放大实验、设备/工艺验证,配液、灌装、冻干、检验、完整性检测、贴标签及装盒等的整套服务,符合美国食药监局、欧洲药品管理局、中国食药监局及日本法规机构的要求。
OncoGenerix is the NEW STATE OF THE ART in oncology injectable process development manufacturing services.
基纳瑞克斯的肿瘤注射工艺开发及生产服务为当今最先进及最高水准的技术水平。
The VALUES of OncoGenerix are OPERATOR SAFETY, ENVIRONMENTAL SAFETY, QUALITY COMPLIANCE.
基纳瑞克斯的价值观为操作员安全、环境安全、质量第一及合规性。
OncoGenerix utilizes ADVANCED ASEPTIC MANUFACTURING TECHNOLOGY PROVEN METHODS to cost effectively manufacture sterile injectable products of the highest possible quality.
基纳瑞克斯采用了先进的无菌生产技术及经过验证的方法生产高性价比高品质的无菌注射产品。
OncoGenerix operates within a highly defined risk-based QUALITY MANAGEMENT SYSTEM reflecting the most current regulaty guidelines f the management of the product life cycle.
基纳瑞克斯公司在高度界定的基于风险的质量管理体系下运行,体现了产品生命周期管理的最新的监管准则。
The OncoGenerix Mudanjiang manufacturing site is 40,110m2 with approximately 18,300 m2 of facilities, including:
基纳瑞克斯牡丹江生产现场40,110m2,设施大约18,300 m2,包括:
· Production Facility (5,700M2)
生产楼(5,700M2)
· GMP Warehouse (1,200M2)
GMP仓库(1,200M2)
· Central Utilities Building (1,100M2)
中央公用工程楼(1,100M2)
· Staff Facility (1,500 M2 Completion 2017)
员工楼(1,500 M2,2017年完成)
· Administration / Development Lab Facility (11,600 M2 Completion 2018)
行政/研发实验室(11,600 M2,2018年完成)