任职要求/岗位职责
岗位职责:
Responsibilities:
1、负责化验室、生产、中间体、原料、成品的检测工作；
Responsible for check laboratory, production, intermediate product, raw material, finished product.
2、负责产品的生产过程跟踪监督；GMP文件的记录、管理等；
Overseeing and follow-up the production process; GMP documents and records will be managed etc.
3、生产过程的质量记录，分析生产中出现的问题，制定解决措施；
Recording the inspection, analyzing upcoming problems, find methods to effectively solve problems and at the same time find and implement measures for prevention.
4、贯彻、执行有效的质量管理体系，确保质量管理体系与GMP及客户要求保持一致；
Ensure effective quality control system and its compliance with GMP, internal requirements and the requirement of customers.
5、对所有的机器/设备，校准，记录保存进行管理；
Manages all machine/ equipment calibrations, records kept.
6、对进料/生产中和出货的产品进行有效的质量控制；
Ensures efficient quality control for incoming/ in process and outgoing products.
7、与项目组成员合作，确保项目的质量计划能有效地执行；
Working with other project team members, ensure the quality objectives and plans are effectively implemented.
8、提出合理化建议；
Give reasonable suggestion concerning QMS and quality control to all departments.
9、协助行政部门的公司质量体系内部审核工作；
Assist Administration Dept. with the internal quality system audit .
10、其他指定任务。
Other tasks as assigned.
岗位要求:
Qualifications:
1、生物化学等相关专业，大专以上学历；
Junior college degree in biochemistry or similar,
2、3年以上发酵、提炼中间体及原料检验经验；1年以上管理经验；
At least 3 years experience in test zymolysis , intermediate product, raw material; at least 1 year experience in management.
3、熟练操作化验室的各类仪器；
Be familiar with all kinds of instrument;
4、熟悉GMP规范；
Be familiar with GMP;
5、化验员上岗证；
Analyst work license
6、仔细、热情；良好的沟通技巧，出色的计划、组织、分析、总结能力。
Careful and enthusiastic; good communication skills; highly planning, organized, analytical. summing-up skills.
工作地点：西安 永寿
Location: Xi An Yong Shou
企业介绍
德壹医疗用品（上海）有限公司
德壹（上海）生物技术有限公司
德壹公司于 1981年成立于日本东京，原名为Tokuichi，主要从事生物类产品贸易。在90年代，德壹公司在美国芝加哥成立生物技术分公司，2000年公司总部搬至美国华盛顿州Bellingham市。同年，在中国成立生产工厂及合资公司，将在美国实验室的研究成果转换为成品，主要产品包括Blasticidin S HCl, Hygromycin B, G-418 Sulfate, Puromycin 等。
1999年美国公司总部在上海投资成立德壹医疗用品（上海）有限公司，公司位于嘉定区江桥镇。德壹嘉定公司主要产品为兽用医疗器械，例如注射器、针尖等，主要用于农场养殖的猪、牛等牲畜以及宠物等防疫和治疗等方面，所有产品出口至欧洲或美国。公司一些产品已经在美国和欧洲取得了专利权，例如公司的新产品IBD和IB针（智能挡块针），这是一种具有特殊挡块的针，可以防止动物在注射药物时发生意外。
中国公司的化工研发部门一直在嘉定兽用医疗器械公司内部，随着项目的增多，业务规模不断扩大，在2009年，我们新成立了独立的研发中心-------德壹（上海）生物技术有限公司，公司位于上海市松江区佘山镇。公司拥有占地超过6000平方米的实验室，具有3x 5吨发酵罐的中试车间，同时我们仍在继续扩大规模。公司主要是为原料药公司提供发酵工艺分析和改进等技术支持。我们已经与挪威Axellia公司就多种菌种改良进行了成功地合作，今后也将就发酵过程优化和新菌种的开发进行合作。
关注客户需求、期望和希望，我们尽全力满足客户的期望。德壹公司以客户为中心，高度关注市场需求及客户的反馈信息，不断提高并获得客户的满意和市场份额。
德壹公司的理念：质量和对客户的承诺，无论何人、何时、何地。
Toku-E was established in 1981 in Tokyo, Japan and under the name of Tokuichi mainly involved in Biochemical trading at that time. During the 90th Toku-E developed a Biotechnology division in the US, first in Chicago and later in 2000 the headquarters moved to Bellingham in the state of Washington, USA. At the same time facilities and co-operations in China were opened, where the research of years, made in the US laboratories paid off. Toku-E had researched specialty antibiotics for bioresearch industries, such as Blasticidin S HCl, Hygromycin B, G-418 Sulfate, Puromycin where finally produced.
Toku-E Medical Devices Co. Ltd, was established in 1999 in Shanghai. Our facility is located in Jiangqiao Town, Jiading District, which is a foreign investment by our American headquarter. In Jiading Toku-E produces medical devices, such as syringes and needles. All devices are used for animals, and exported to EU or USA where they are mainly used for the swine cattle and pet industry. Some of our products have been patented in US and Europe, such as our newest invention the IBD and IB needle (Intelligent Block needles) which feature a special block function to protect the animal from accidents during injection.
For many years our China research centre was located right next to our animal health facility but since 2009 we have our own separated research and development centre. Toku-E (Shanghai) Biotechnology Co, Ltd. was established in June 2009 and is located in Sheshan Town, Songjiang District Shanghai. On over 6,000 square meters of laboratories, an attached pilot plant with 3x 5t fermenters we are constantly extending our research efforts. We offer technical support, such as fermentation process analysis and strain improvement, to API companies. We have been cooperating with Axellia from Norway on various strain improvements and are continuing to join our forces together, concerning optimization of fermentation and new strain development.
We pay attention to our customers needs, expectations and wishes and try to always exceed their expectations with all our effort. Toku-E is customer focused and pays highest attention to market needs and feedback from its customers to continuously improve and gain customer happiness and market shares.
Our philosophy:
Quality and customer commitment, everywhere, everyone, every time.
