1.Verify alignment between the quality operations and RA activities related to the EU product marketing authorizations and EU GMP requirements.

确认质量运营、与欧盟产品上市许可相关的法规事务活动与欧盟GMP要求相符合。

2.Participate when required, on the qualification and monitoring process of all suppliers providing services for the production and testing of EU products (i.e. Third party laboratory qualification, primary packaging components, and APIs suppliers).

需要时，参与为欧盟产品生产和测试提供服务的所有供应商(例如，第三方实验室确认、内包装组件和API供应商)的确认和监测过程中。

3.Ensure there is no gap between site quality/operations system and EU client quality and supplier agreements.

确保现场质量/运营系统与欧盟客户质量和供应商协议之间无缝对接。

4.Work hard to hand with the engineering TTD department, laboratories, and customer’s Qualified Person for the transition of EU products to manufacturing.

努力与工程部技术转移部门、实验室及客户质量授权人合作，将欧盟产品转移到现场生产。

5.Responsible to overview the assembly and presentation of the site Annual Product Review in accordance to written procedures.

负责按照书面规程概述现场年度产品审核的汇总和展示。

6.Manage and present site Metrics in the Monthly Management meetings.

管理现场指标和阅读管理会议。

7. Acts as primary on- site CMO host and EU regulatory inspections.

作为首要的现场委托加工机构主持人和欧盟法规检查员。

8.Acts as primary on-site CMO and client routine audits and Qualified Person on-site visit.

作为首要的现场委托加工机构主持人、客户日常审计人员和现场参观的质量授权人。

9.Establishes, refines, implements, and maintain proper QA system and procedures for the company’s compliance with EU GMP-CMO operations.

建立、细化、执行和维护适当的质量保证体系和规程，以使公司符合欧盟GMP-委托加工机构运营。

10.Ensure that the systems affecting product quality for product marketing in Europe (e.g. batch records, testing, SOPs, validation protocol/reports) are consistent and in full compliance with customer requirements and that the customer’s Qualified Person is part of the change control process.

确保影响在欧洲销售产品的产品质量的各个系统（例如，批记录、检测、SOPs、验证方案/报告）的一致性并完全符合客户的要求；确保客户的质量授权人是变更控制流程的一部分。

11.Design and implement a process flow to ensure data governance review is always observed.

设计并执行工艺流程，确保始终遵循数据管理评审。

12.Final verification of Master batch records, Material Specifications for APIs, components, label/labeling components, excipients, and Finished products to ensure all activities such as sampling, testing, environmental monitoring, production instructions, and yields have been properly documented, and that the storage requirements are in accordance to the materials and finished products requirements.

对主批记录、APLs物料说明、成分、标签/标记组件、辅料和成品的最终确认，以确保所有活动，如取样、测试、环境监测、产品说明和产量被合理记录，并确保储存符合材料和成品的要求。

13.Certified and provide EU product batch records to the Qualified Person ensuring that the product has been released after the verification of data and data integrity review following the EU GMP requirements.

证明，并向质量授权人提供欧盟产品批记录，确保产品按照欧盟GMP要求进行数据确认和数据完整性审核之后被放行。

14.Work closely with the RA department on the review and assembly of regulatory documentation for client’s QP regulatory submissions.

与法规事务部紧密合作，为客户质量授权人递交法规申请，审核并装订法规记录。

15. Evaluate, compile, and provide the annual product data trending and/or raw data upon EU- QP client’s request for EU product reviews.

欧盟-质量授权人要求对欧盟产品进行审核时，评估、汇编并提供年度产品数据趋势和/或原始数据。

16.Participate in the Monthly Management Meeting.

参加月度管理层会议。

17.Responsible for leading the site Risk Management Process.

负责领导现场风险管理流程。

18.Maintains job proficiency and technical knowledge by attending educational workshops; reviewing professional publications; establishing personal networks and participate in professional societies.

通过参加教育研究班，查阅专业刊物，建立人脉网络，参加专业协会，精进工作能力和专业知识。

19.Complete any other work task assigned by superior or designee.

完成上级或授权人安排的其它工作。

上班地址：海林市海林经济开发区东旭路7号

Do you want a brighter future?
您向往远大前程吗？
Are you looking for advancement and a great career?
您正在寻求职位晋升和伟大的职业生涯吗？
Do you want FDA, EU and CFDA regulatory experience?
您想获得FDA, EU 和 CFDA监管经验吗？
If you are Dedicated, Honest, Responsible and Passionate to learn. OncoGenerix ltd. is the company is for you!!!
如果你敬业，诚实，负责并乐于学习， 那么基纳瑞克斯正是为你量身打造的公司。
OncoGenrix ltd. is a pharmaceutical company based in San Diego, California, USA. Our manufacturing site located here in China.
基纳瑞克斯是一家制药公司，总部位于美国加利福尼亚圣地亚哥,生产基地位于中国。

OG Introduction
基纳瑞克斯简介
Our manufacturing facility located in the scenic Hailin of Heilongjiang Province in the northeastern part of China. OG is located Hailin is featured with pleasant climate, short frost-free period, and with rich forest resources for hiking and skiing. There are five unique tourism resources including:
我们的生产基地位于中国东北黑龙江省风景如画的海林。海林气候宜人，无霜期短，丰富森林资源供远足和滑雪。那里有5个独一无二的旅游资源：
largest Siberian Tiger sanctuary and Zoo,
最大的东北虎饲养保护区，
earliest “August 1” mountain ski area of Chinese People’s Liberation Army (national ski-training base),
最早的中国人民解放军“八一”高山滑雪场（***滑雪训练基地）；
three national forest park such as Tiger Mountain, Foshoushan and China Snow Town and lianHuahu national Geopark,
威虎山、佛手山、中国雪乡三个***森林公园和莲花湖***地质公园；
The high mountain barrier lake—Jingpo Lake with the biggest size in China and the second in the world is located in Hailin,
中国最大、世界第二大高山堰塞湖-镜泊湖；
16 historical sites since Shang and Zhou Dynasties.
16处自商周以来的历史遗址。
In addition, our city is located in a very strategy area with a high speed train station which can take you to any major cities within a short travel time period. Cities like Harbin, and other have many other scenic and historical areas which you can visit at your leisure time. For example the famous Worldwide know “Ice festival from January to February, Aquarium, Zoo, and many other historical sites.
另外，我们的城市位于战略区。高铁可以在短时间内带你到任何一个大城市。比如哈尔滨和许多其它风景区和历史遗址可以在闲时参观。例如世界闻名的1月-到2月的冰雪节，水族馆，动物园和许多其它历史遗迹。

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。

OG was established in 2012, OG Hailin facility designed by the professional American team is the pharmaceutical company mainly manufacturing the lyophilized and solutions anticancer drugs. The company is a GMP CFDA manufacturing certified for the lyophilized products since 2017, EU German Authorities GMP certified since 2018 and ISO9001 certified since October 2018.
At present OG has already entered into cooperative manufacturing agreements with companies from China, EU and the United States.
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。

OG offers a great environment to work and great opportunity for growth. We count with around 200 hundred professionals in which 208 are composed with employees between the ages of 23 and 45. Offers a well balance of well experienced personnel and just recent graduate employees. Diversity is important in our facility; therefore, we count with a facility in that we have integrated mostly men/women Chinese personnel 96.5% and remaining 3.5% from other countries such as USA, India, and other European countries. This will give you a great opportunity to work in an American company and learn GMP requirements from EU, USFDA, and China FDA, interact with foreigners to learn from their working experience, their cultures, and expand your friendship scope. Our facility culture is based on honesty, integrity, team work and team decision making.
OG提供工作的大环境和成长良机。我们总计有大约200名专业人士，23岁 和 45岁年龄的员工组成。很好平衡工作经验丰富人士和刚毕业员工。多样性在我们的工厂非常重要；因此，我们的工厂包括男女中国员工96.5%和来自美国，印度，和其它欧洲国家的员工3.5%。工作在美国的公司给你巨大的机会，学习欧洲，美国 FDA和中国FDA的GMP要求，接触外国人学习他们的工作经验，文化，并扩大你的交际圈。诚信，正直，团队协作和集体决定是我们公司文化基础。

For details on our facility refer to our company website: www.oncogenerix.com
我们工厂详情请登陆公司网站：www.oncogenerix.com