更新于 12月24日

QC经理

6千-8千
  • 宿迁宿豫区
  • 5-10年
  • 大专
  • 全职
  • 招3人

职位描述

原料药QC

岗位职责:

1、负责制定审核分析检验操作规程及质量标准,领导QC的所有GMP文件和技术文件的起草,审阅和批准,全面管理QC部门工作;

2、负责审核原始记录及检验报告单,对偏差或异常数据进行调查及处理,签发报告书(授权);

3、指导QC部门的各项验证工作,审核并执行验证工作,组织稳定性研究,保证检验人员严格按检验操作规程操作;

4、监督实验室安全工作,管理下属人员的培训与考核,协调并监督部门内部各项工作;

5、建立与维护检测方法与条件,建立仪器设备验证与维护管理;

6、负责部门的预算编制。

任职资格:

1、大专及以上学历,药学相关专业(初级专业技术职称),具有至少八年从事药品质量控制管理的实践经验;

2、掌握一定的药物分析理论及检验知识,熟悉产品知识、药品生产作业流程;

3、熟悉GMP体系,能够对仪器操作过程、理化实验过程、数据及计算作分析;

4、熟悉行业相关法规,熟悉生产工艺过程和药品检验流程;

5、具备较强的组织协调,问题处理能力及团队协作精神。

职位福利:

高温补贴、缴纳五险、提供食宿、带薪年假、定期体检

工作地点

宿迁生态化工科技产业园扬子路20号

职位发布者

许娜/人力资源经理

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公司Logo江苏慈星药业有限公司
江苏慈星药业有限公司成立于2013年,座落于中国江苏宿迁市生态科技产业园扬子路20号,是专业生产销售医药原料药、药用辅料、医药中间体的制药公司,公司现有员工120人,拥有高级技术管理人员25人。公司拥有一套完整的合成加工和成品包装车间,并建好6500平米符合新版GMP要求的净化车间。公司成立以来,在客商的鼎立支持和全体员工的努力下,得到迅速发展,目前拥有准字号原料批文18个。并具有规范的质量管理体系及先进的质量控制手段。部分产品已通过PQ认证。产品执行 CHP、 USP、 EP、 BP等国内、国际标准。Jiangsu Ci Xing Pharmaceutical co., LTD., founded in 2013, is a professional pharmaceutical company specialized in manufacturing and selling active pharmaceutical ingredients, pharmaceutical excipients and medical intermediates located in No.20, Yangzi Road, Ecological Science and Technology Industrial Park, Suqian City, Jiangsu, China with an existing staff of 120 people, including 25 senior technical managers. The company has an integrated workshop for synthetic processing and product packaging as well as a built purification plant of 6,500 square meters that meets the requirements of new GMP. Ever since its establishment, the company has been developing rapidly based on firm support of our merchant customers and endeavor of the whole staff. Currently the company has 18 medicine ingredients’ approved numbers, standard quality management system and advanced quality control means. Part of our products have been certified by PQ. All our products are in accordance with domestic or international standards including CHP, USP, EP, BP and so on.江苏慈星药业有限公司拥有一批致力于医药事业的各类年轻的专业技术及管理人才的同时,仍向社会广招贤才,力争把新品研发与技术改造、质量管理与质量控制、产品销售与服务、生产与设备管理等方面精于求精,更上一层,勇于创新,积极进取,在不久的未来江苏慈星药业有限公司将会在医药原料药合成领域做得更好,走的更远。Despite equipped with a group of all kinds of young professional technical and management talents who dedicate themselves to medicine business, Jiangsu Ci Xing Pharmaceutical co., LTD. still seeks more talents from the society. We are striving to be better, advanced, more creative and more aggressive in all aspects including new product development, technical innovation, quality management, quality control, product sales, customer service, production and equipment management. In the near future, Jiangsu Ci Xing Pharmaceutical co., LTD will do a better and further job in the field of active pharmaceutical ingredients synthesis.
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