牡丹江招聘

1.Ensure that all production personnel are appropriately trained for their positions.

  

确保所有的生产计划人员已接受恰当的岗位培训。

  

2.Prepare, review, implement and maintain Production Planning SOPs.

  

起草、审核、实施和维护生产计划SOP。

  

3.As required, participate in the Weekly Operations Organization Meeting to review trended Manufacturing data, staff requirements and quality issues.

  

根据需求，参加每周的运营部门会议以审核生产数据趋势分析、员工要求和质量议题。

  

4.Assist with the prepare production plan for products to be manufactured against the monthly requirements of the Business Department.

  

根据业务部门的月度需求，协助准备产品的生产计划。

  

5.Assist with the tracking of the product manufactured against the production targets and product mixes defined.

  

根据定义的生产目标和产品组合，协助跟踪生产的产品。

  

6.Through the Business Department assist with the ordering of manufacturing consumables, components and materials required against the monthly requirements of the Business Department and the production targets and product mixes defined in the Annual Plan.

  

根据业务部门的月度需求和年度计划中定义的生产目标和产品组合，通过业务部门协助订购所需的生产耗材，部件和材料。

  

7.Assist with the scheduling of manufacturing resources training and retraining.

  

协助安排生产资源培训和再培训。

  

8.Assist with the scheduling of equipment & systems calibration and systems preventative maintenance.

  

协助安排设备和系统的校准和系统的预防性维护。

  

9. Assist with the Schedule batch manufacture date(s).

  

协助安排批次生产日期。

  

10.Track equipment & systems uptime availability, faults and failures.

  

追踪设备&系统的运行时间的有效性、故障和失效。

  

11. Assist with the tracking of manufacturing process yields and reject data.

  

协助跟踪生产工艺产量和拒收数据。

  

12.Ensure that the required Manufacturing resources are available to meet production targets while maintaining product quality.

  

确保必需的生产资源的有效性，在保证产品质量的同时符合生产目标。

  

13.Provide technical mentorship to Manufacturing staff.

  

为生产部员工提供技术辅导人员。

  

14.Write, review and approve SOPs generated and required by Manufacturing.

  

编写、审查和批准生产部生成和需要的SOP。

  

15.Report critical quality / compliance issues to Executive Management immediately.

  

及时向执行管理层报告关键的质量/符合性问题。

  

16.Work with the Quality, Operations and GMP Accounting Organizations to ensure that the OncoGenerix systems are operating in compliance.

  

和质量部、运营部和GMP财务部共同确保基纳瑞克斯的体系合规运营。

  

17.Where appropriate participate in risk management / risk review meetings, failure investigations associated with the Manufacturing Department.

  

在适当的参与风险管理/风险评估会议，与制造部门相关的故障调查。

  

18.Assist with the manufacturing activities for new product development.

  

协助新产品开发的生产活动。

  

19.When require assist with the implementing of production plans for site operations ensuring the product changeover is appropriate to guarantee non-interrupted supply of marketed products.

  

负责制定和实施公司运营的生产计划，确保通过恰当的产品轮换生产方式，保证上市产品的无间断供应。

  

20.Responsible for managing the formulation and filling operation of products are performed and documented accordantly.

  

负责管理确保产品的配液及灌装操作和记录一致。

  

21.Responsible for implementing and managing an effective cleaning process and product changeover programs to prevent the product contamination and cross contamination during product manufacture.

  

负责执行和管理清洗过程的有效性及产品运转流程，防止在产品的生产制造过程中产生污染和交叉污染。

  

22.Responsible for reviewing product batch production records, ensuring the batch production records are accurate, complete and correct.

  

负责公司各产品批生产记录的审核工作，确保各产品批生产记录的准确、完整、正确。

  

23.Responsible for the monitoring of the production area and equipment temperature, humidity, viable, Non-viable environmental monitoring systems.

  

负责监测生产区域和设备的温度、湿度、可行、不可行的环境监测系统。

  

24.Responsible to ensure the cleaning, sanitization and or decontamination of the cleanroom areas and equipment are performed and properly documented.

  

负责确保洁净区和设备的清洗、消毒或净化操作实施且正确的记录。

  

25.Oversee the process formulation and filling process (materials processing, parts and set up assembling, process sampling, area/ line clearance) is accordance with the batch records.

  

监督工艺配方和灌装过程（物料的加工，零件的装配，过程取样，区域/线的间隙）符合批记录。

  

26.Perform other activities assigned by management.

  执行经理安排的其他活动。

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