1. Responsible for the site quality audit program. Includes maintain SOPS, site annual scheduling, monitoring and follow up to audit findings and completion of commitments。

负责现场质量审计活动，包括维护SOP,制定现场年度审计计划、监督、跟踪审计结果和任务完成情况。

2. Responsible for the Supplier quality audit program to include supplier qualification ，supplier’s approved list, and annual product monitoring program.

参与供应商管理程序包括供应商确认、供应商批准清单和年度产品监控程序。

3. Ensures compliance with established internal control procedures by examining records, reports, operating practices, and documentation.

通过审查记录、报告、实际操作及文件纪录情况，确保符合已建立的内部控制规程。

4. Participate on Vendor Corrective Action (VCAR) Plans and maintain the monitoring of the VCAR system.

参与供应商纠正措施(VCAR)计划并对VCAR系统进行监控。

5. Completes audit work papers by documenting audit findings. Maintain files generated from each audit.

通过记录审计结果完成审计文件,并维护此文件。

6. Appraises adequacy of internal control systems by completing audit questionnaires.

通过完成审计调查问卷，评估内控体系是否得当。

7. Maintains internal control systems by updating audit programs and questionnaires; recommending new policies and procedures.

通过对审计活动和调查问卷进行更新，维护内控体系，推荐新程序和流程。

8. Communicates audit findings by preparing a final report; discussing findings with auditees.

通过编写最终报告告知审计结果，和被审计方就审计结果进行讨论。

9. Complies with federal, state, and local security legal requirements by studying existing and new security legislation; enforcing adherence to requirements; advising management on needed actions.

通过学习现有和新的安全法规，遵守（美国）联邦、州和地方法规的要求并强制执行；对需要采取的行动提供管理建议。

10. Prepares special audit and control reports by collecting, analyzing, and summarizing operating information and trends.

通过收集、分析和总结运行数据和趋势，准备特种审计和控制报告。

11. Maintains professional and technical knowledge by attending educational workshops; reviewing professional publications; establishing personal networks; participating in professional societies.

通过参加培训研讨会、研读专业文献、建立人际网络、参加专业社团，保持专业技术知识水平。

12. Provides internal communication regarding compliance issues and applicable regulation changes.

合规性问题及适用法规出现变化时，与内部进行交流。

13. Aids in the creation of gap analysis to any new/changed regulations.

在新/修订法规引起差距分析时，提供帮助。

14. Work with the departments audited to resolve compliance issues, provide recommendation, communication on status of action resolution and bringing to management issues that require attention tracking corrective actions.

与接受审计的部门合作解决合规性问题，并提出建议、沟通解决行动的状态，将需要留意跟踪的纠正问题上报于管理层。

15. Participate on Vendor Corrective Action (VCAR) Plans and maintain the monitoring of the VCAR system.

参与供应商纠正措施(VCAR)计划并对VCAR系统进行监控。

16. Complete any other work task assigned by Quality Assurance Manager.

完成质量保证部经理分配的其他工作任务。

上班地址：海林市海林经济开发区东旭路7号

基纳瑞克斯简介
With our corporate headquarters located in San Diego, California, USA and our manufacturing facility located in the scenic Hailin of Heilongjiang Province in the northeastern part of China. Established in 2012, OG Hailin facility designed by the professional American team is the pharmaceutical company mainly manufacturing the anticancer drugs. The company received the manufacturing permit for the lyophilized products and solution products in 2017. The company passed the site audit of lyophilized products from EU GMP in 2018 and passed the ISO9001 certification in October 2018. At present OG has already entered into the cooperative agreements with companies from China, EU and the United States. In 2019 OG will establish key offices in Shanghai/Nanjing for accomplishment of listing and commercialization.
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海林市。基纳瑞克斯海林工厂创立于2012年，是一家由美国专业团队打造，以生产抗癌药物为主要经营的制药公司，在2017年收到了冻干产品和溶液产品生产许可证。次年（2018年）通过了欧盟GMP对冻干产品的现场审计。同年（2018年）10月通过了ISO9001认证。目前基纳瑞克斯已和中国，欧盟，美国等公司签订了合作协议。2019年基纳瑞克斯生物将在上海/南京建立关键办事处，以完成上市和商业化需求。
OncoGenerix offers a fully integrated suite of services including technical transfer, process development, scale-up, equipment / process validation, formulation, filling, lyophilization, inspection, integrity testing, labeling and cartoning meeting the requirements of the US FDA, EMA, CFDA & Japan Regulatory.
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 and 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 and 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 and 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 regulatory guidelines for 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 40,110㎡ with approximately 18,300 ㎡ of facilities, including:
基纳瑞克斯牡丹江生产现场40,110㎡，设施大约18,300 ㎡，包括：
Production Facility (5,700㎡)
生产楼(5,700㎡)
GMP Warehouse (1,200㎡)
GMP仓库 (1,200㎡)
Central Utilities Building (1,100㎡)
中央公用工程楼(1,100㎡)
Staff Facility (1,500 ㎡)
员工楼(1,500 ㎡，)
Administration / Development Lab Facility (11,600 ㎡)
行政/研发实验室(11,600 ㎡)
Hailin is featured with pleasant climate, short frost-free period, rich in forest resources and high forest coverage up to 78%. There are five unique tourism resources including “snow, tiger, mountain, water and feeling”, with the world’s largest cultivation base of Siberian Tiger; There is the earliest “August 1” mountain ski area of Chinese People’s Liberation Army (national ski-training base); there are three national forest park such as Tiger Mountain, Foshoushan and China Snow Town and lianHuahu national Geopark; The high mountain barrier lake—Jingpo Lake with the biggest size in China and the second in the world is located in Hailin, with 16 historical sites since Shang and Zhou Dynasties.
黑龙江省海林市一个气候宜人，无霜期短，林木资源丰富，森林覆盖率达78%的城市。这里有“雪、虎、山、水、情”五大特色旅游资源，其中有世界最大的东北虎饲养育基地；有全国最早的中国人民解放军“八一”高山滑雪场（是***滑雪训练基地）；有威虎山、佛手山、中国雪乡三个***森林公园和莲花湖***地质公园；有中国最大、世界第二大高山堰塞湖-镜泊湖；有16处自商周以来的历史遗址。
The Yabuli International Ski Resort, the original Russian name гесперид “Apple Garden” was the hunting ground for feudal lords during the Qing Dynasty (1644-1911). With the biggest ski area and comprehensive snow training center in China at present, Yabuli Ski Resort is used for holding the international and domestic competition and skiers with the intermediate and high level.
亚布力滑雪场俄语原名亚布洛尼，“果木园”之意。清朝时期为皇室及满清贵族的狩猎围场。亚布力滑雪场是目前国内最大的滑雪场，也是我国目前最大的综合性雪上训练中心。主要用于举办国际国内竞赛，也可供中、高级滑雪水平的滑雪者使用。
China snow town is located at the junction of Zhangguang Cai ridge and Laoye ridge under Changbai Mountain region. The frequent junction of web-warm air from Sea of Japan and the cold wind from Lake Baikal and the microclimate of high mountains and dense forests have a tremendous impact on China snow town. There are no three sunny days in summer and the scenery of snow in the forest is picturesque. And the snow period here lasts more than 7 months from October to April of next year and the average snowfall reaches 2 meters. China snow town is famous for big amount of snow and excellent snow quality and high viscosity.
雪乡景区座落于长白山脉张广才岭与老爷岭交汇处，因贝加尔湖冷空气与日本海暖湿气流在此频繁交汇，以及山高林密的小气候影响，形成了夏无三日晴，冬雪漫林间的景象，每年十月开始降雪至次年四月，雪期长达7个月，积雪厚度可达2米左右，雪量堪称中国之最，且雪质好，粘度高，素有“中国雪乡”之称。
The Siberian Tigger Park is the biggest base for breeding and mountain and forest free-ranging of Siberian Tigger in Northeast region, which is known as “China Tiger Town”. It is the largest natural park for wild Siberian Tigers in the world at present. The Siberian Tigger Park is located at the foot of
Foshou Moutain under Zhangguang Cai ridge. This park is surrounded by the mountains and green forest. With the similar natural habitat for Siberian Tiger including mountain, forest and stream here, this park is particularly suited to breeding and wild environment survival training for Siberian Tigger.
东北虎林园是我国东北地区最大的东北虎繁育、山林散养基地，有着“中国虎乡”之美称。虎林园坐落在张广才岭山脉佛手山脚下，这里四周群山环绕、林木蓊郁，园内有山、林、溪，与东北虎自然生长的环境非常相似，特别适合东北虎的饲养繁育与野化训练。
There are scenic stone peaks, strangely-shaped pines and grotesque rock, primeval forests and pine acres in the small Jiuzhai Valley, with rare flowers &grasses, simple and secluded environment and dense aroma. The splendid rare northeast high mountain group falls run regularly all through the year.
The old trees that reach into the sky and the unique scenery of northern China are not only enjoyable, you can also experience the mystery of forest and artistic conception of Tracks in the Snowy Forest. With lush green mountains and the spring flushing in the mountains, there is no humans but only the sound of running water in mountain. Drifting in Weihu Mountain, fast stream thrilling stimulation, steady stream be passionate and romantic, picturesque scenery here with great charm, you seem to walk around in the painting.
小九寨内有多座秀丽的石峰、奇松怪石，原始森林高耸挺拔，红松成片， 各种奇花异草相互辉映，林中环境古朴清幽，花气袭人.由于落差较大，多处跌水而形成壮观的东北罕见的高山瀑布群、山泉叠落、终年不息。这里不仅可赏森林参天古木，也可观北国独特风光，亲身体验大森林的神秘和林海雪原的意境。这里群山一片葱郁，泉溪流水在山间奔流，绝无人迹之处，只有空山响彻着流水的声音。威虎山第一漂，急流惊险刺激、稳流激情浪漫，山清水秀、景色怡人。漂流沿途自然风光秀丽，好似“桂林石林”的石砬子山伸手可触，人在青山碧水中畅游，如同身在画中一般
Jinpo Lake is the volcanic lava barrier lake. The lake flows northeastward to another end of northern lake and to the waterfall pool. This pool was called “Faku” by Manchu namely “Sea Eye”. The lake flow to Mudan River from this pool.
镜泊湖是火山熔岩堰塞湖。全湖东北流向，流至北湖北，再向东北泻出注入瀑布深潭。满语称此潭为“发 库” ，即“海眼”之意，湖水从此处流入牡丹江中。