1.Responsible for the development, implementation and maintenance of the laboratory quality management system (QMS), and for ensuring that testing and practices are up to current standards.
负责实验室质量管理系统（QMS）的开发、实施和维护，确保检测和实践符合现行的标准。
2.Follow local and international drug regulation.
遵循当地和国际药品法规。
3.Responsible for the review of the quality control documents, including in-house specifications, sampling operation procedures, testing operation procedures, and storage standards of raw materials and excipients, packaging materials, intermediate products, bulk products and finished products.
负责质量控制文件的审核工作，包括原辅料、包装材料、中间产品、待包装产品和成品的内控质量标准、取样操作规程、检验操作规程和贮存标准。
4.Prepare QC (Microbiology and Chemistry laboratories) staff job descriptions.
起草QC(微生物和化学实验室)员工的职位描述。
5.Hire QC staff with the support of Executive Management.
在执行管理层的支持下雇佣QC员工。
6.Undertake QC staff reviews.
承担QC员工的审核工作。
7.Responsible for the training management of labs quality system.
负责实验室质量系统的培训管理工作。
8.To ensure that the required initial and continuing training of her department personnel is carried out and adapted according to need.
确保对本部门实施了所需要的最初培训与持续培训。
9.To ensure the appropriate hygiene requirements of her department.
确保本部门适当的卫生要求。
10.The authorisation of written procedures and other documents, including amendments.
书面程序和其他文件的授权，包括修改。
11.Review and approve SOPs generated for the QC areas.
审核和批准QC部门生成的SOP。
12.To approve specifications,sampling instructions,test methods and other Quality Control procedures.
批准质量标准、取样说明、检验方法以及其他质量控制程序。
13.Manage the development and validation of microbiology and chemistry test methods. Review and approve new and changes to existing test methods.
管理微生物和化学检验方法开发和验证工作，审核和批准新的检验方法和现有检验方法的变更。
14.The inspection,investigation,and taking of samples,in order to monitor factors which may affect product quality.
对样品进行检查、调查和取样，以监测可能影响产品质量的因素。
15.To ensure that all necessary testing is carried out and the associated records evaluated.
确保实施了所有必需的检验和相关记录的审核。
16.Report critical quality control issues to Executive Management immediately.
及时向执行管理层报告关键质量控制问题。
17.Support QA on any investigation requiring further testing.
当QA 在任何调查需要进一步的检测时提供支持。
18.To ensure the monitoring and control of the manufacturing environment.
生产环境的监测与控制。
19.Manage new product development activities for OG and external clients.
为OG和外部客户管理新产品的开发活动。
20.To approve and monitor any contract analysts.
批准和监督任何外包测试。
21.Active participation on review of quality agreement.
积极参与质量协议的审核。
22.To ensure the qualification and maintenance of her department,premises and equipment.
确保本部门场地和设备的确认与维护。
23.To ensure that the appropriate validations are done.
确保实施了适当的验证。
24.The monitoring of compliance with the requirements of Good Manufacturing Practice.
监测与GMP要求的一致性。
25.Involvement in all GMP related matters or issues.
参与所有与GMP相关的事项或问题。
26.Develop and implement product development plans
开发和实施产品开发计划。
27.Work with the Quality Operations and GMP - Accounting Organizations to ensure that the OncoGenerix systems are operating in compliance.
与质量运营部及GMP财务部紧密合作以确保基纳瑞克斯的体系合规运营。
28.Participation in management reviews of process performance,product quality and of the quality management system and advocating continual improvement.
参与工艺流程、产品质量和质量管理体系的管理评审，提倡持续改进。
29.Ensuring that a timely and effective communication and escalation process exists to raise quality issues to the appropriate levels of management.
确保及时有效的沟通和升级工艺以提高质量管理的水平。
30.Work with QA / RA Department Manager to prepare and implement statistical analysis techniques to accurately trend and document the performance of QC systems.
与QA/RA部门经理一起制定实施统计分析技术以准确的分析和记录QC系统的性能。
31.Responsible to provide data for periodic departmental quality meetings to discuss on going activities, current trends, issues, resolutions, new projects, and plans.
负责向定期召开的部门质量会议提供数据, 就正在进行的工作、目前的趋势、问题、决议、新项目及计划进行讨论。
32.Prepare the Quality Control systems performance report (statistical analysis) for the Weekly Quality Organization Meeting to review trended quality data, staff requirements and quality issues.
为每周的质量部门会议起草质量系统性能报告（统计分析）以审核质量数据的趋势、员工需求和质量事物。
33.Maintain the site Stability program for the whole year such as production sampling schedules, samples pull testing, reporting, individual and family product trajectory ensuring that the continuous stability monitoring program of products has been completed, and the stability monitoring data can be presented during quarterly and Annual Product Review meetings.
维护年度稳定性计划，如产品取样计划、样品检测、报告、单品种和系列产品跟踪等，确保产品持续稳定性监测计划已经完成，并且可以在季度、年度的产品审核会议上提交稳定性监测的数据。
34.Participate in risk management / risk review meetings.
参加风险管理/风险审核会议。
35.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。
36.Complete any other work task assigned by Director Quality Operations.
完成质量运营总监分配的其他工作任务。
职能类别： 质量管理/测试经理(QA/QC经理)
关键字： 质量控制 GMP体系
联系方式
上班地址：海林市海林经济开发区东旭路7号
公司信息
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
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