1. Manage monthly trending metrics and presentation of the following QMS:
管理月度趋势指标和以下质量管理体系报告:
- Failure Investigation system (NOE, NCRs, CAPA, Laboratory Investigation, Vendor Corrective Action Report , Customer Complaint)
失效调查系统(事件通知,不符合项报告,纠正措施及预防措施,实验室调查,供应商纠正措施报告,客户投诉)
- Water Test Monitoring (Potable, Purified Water, WFI)
水试验监测(饮用水,纯化水,注射用水)
- Pure steam
纯蒸汽
2. Change Control metrics for the current month in comparison with previous month.
对比上月和本月变更控制指标
3. Manage semi-annual Quality trending metrics and presentation in accordance to A-G-SOP-21004
根据A-G-SOP-21004管理半年度质量趋势标准和报告。
4. Manage, coordinate, and present Annual Product Reviews preparation and presentation.
管理、协调和展示《年度产品审核》,制定和提交。
5. Devises sampling procedures and designs and develops forms and instructions for recording, evaluating, and reporting quality and reliability data.
制定取样规程,设计和制定记录、评估和报告质量和可靠性数据的表格和说明。
6. Provides support to QA incoming engaged in measuring and tabulating data concerning materials reliability.
协助QA来料对涉及物料可靠性的数据进行测量并制表。
7. Provides support to QA in process engaged in measuring and tabulating data concerning in process quality and finished product reliability.
协助QA来料对有关中间过程质量和成品可靠性的数据进行测量并制表。
8. Provides support to QC engaged in data measuring and tabulating data concerning materials, process quality and reliability.
协助QC对涉及物料、工艺质量和可靠性的数据进行测量并制表。
9. Maintain the site on-going Reduced Testing Program for API, excipients, packaging materials and other materials if applicable.
如适用,维护现场正在进行的原料药、辅料、包装物料和其它物料的缩减测试程序。
10. Product Yield and rejections evaluation for establishing rejection rates. Trending and evaluation for reconciliation of materials.
产品收率和不合格率评估建立不合格品率。物料平衡率趋势和评估。
11. Leads the overall activities related to the site quality continue improvement program.
领导与现场质量持续改进程序有关的全部活动。
12. Performed any other task assigned by the direct supervisor.
执行直接主管分配的其它任务。
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)