上海 [切换城市] 上海招聘上海质量管理/安全防护招聘上海质量管理/测试经理(QA/QC经理)招聘

QCA Manager

卡博金艾美斯医药(上海)有限公司

  • 公司规模:50-150人
  • 公司性质:外资(非欧美)
  • 公司行业:制药/生物工程

职位信息

  • 发布日期:2020-11-11
  • 工作地点:上海-奉贤区
  • 招聘人数:1人
  • 工作经验:5-7年经验
  • 学历要求:硕士
  • 语言要求:英语熟练
  • 职位月薪:2-2.5万/月
  • 职位类别:质量管理/测试经理(QA/QC经理)  药品生产/质量管理

职位描述

Responsibilities:

1. Manage QC day-to-day activities; organize the laboratory work to ensure analysis are performed in compliance and as per schedule, by developing, deploying and optimizing resources.

2. Lead QC projects (such as Technological and Analytical Transfer Plans, Analytical Method Development, Optimization and Validation) as defined and required.

3. Ensure compliance of equipment, process, procedures, specifications and test methods to the required Quality Standards and Regulatory requirements; ensure compliance status of all analytical records.

4. Manage and review OOS, deviations, stability studies and change control related to QC activities in a timely and compliant manner.

5. Identify and lead continuous improvements initiatives.

6. Manage and control laboratory spending within the planned budget.

7. Represent QC during Health Authorities, Corporate and customer inspections; ensure compliance of EHS guidelines in laboratory operations. Responsible for providing a work environment free from hazard and in compliance with applicable laws and regulations.


Requirements: 

a)   Master Degree/PhD in Science, Analytical Chemistry, or equivalent.

b)   Minimum 5-8 years’ experience in QC managerial/supervisory role, in analytical science and technology, with very good understanding of GMP/API international standards and regulations, and experienced in analytical development /optimization /validation.

c)    Fast learner and good organization skills; fluent in written and oral English and Chinese communication.




公司介绍

卡博金艾美斯集团是一家全球领先的原料药定制研发和生产服务商。同时我们还生产用于临床试验和商业化供应的原料药和成品药。我们擅长于各种复杂和有挑战的化学反应以及工艺放大领域。因此我们掌握大量的化学合成经验,同时基于药品GMP规范管理各类复杂的医药领域的供应链能力。

我们集团在全球拥有8个工厂,分别位于瑞士、中国、法国、英国和荷兰。上海的工厂专注于大规模生产、从中国市场采购化学原料以及临床前新药的试验室开发。目前上海工厂依托100升到6300升不等的各类反应釜执行安全可靠的生产运营,同时我们还拥有一系列的高科技分析设备以支持我们的研发和产品质量检测需求。

上海工厂120位锐意进取的员工,拥有化工和制药领域的良好的学术背景和长期经验。我们不但鼓励员工的专业性和个人职业发展,而且还鼓励全球各工厂之间的项目交流,使员工受益于全球350多名博士的集体知识。

CARBOGEN AMCIS is a market leading supplier for drug substance services for the pharmaceutical industry and also produces both drug substances and final medicines for clinical trials and commercial supply. We excel in the field of complex and difficult chemistry and scale-up. As such, we handle a multitude of chemical reactions, while managing complex supply-chain challenges under Good Manufacturing Practice (GMP) regulations.

Our company has 8 sites around the globe in Switzerland, France, UK, the Netherlands and China. Our Shanghai site is specialised on larger scale manufacturing, raw material sourcing from the large Chinese chemical market, preclinical laboratory development. We execute safely and reliably our production with reactors ranging from 100L to 6’300L. To support R&D and measure our product quality we have a range of high tech analytical equipment.

Our 120 dedicated and motivated employees on site have a good academic background and long experience in the chemical and pharmaceutical industry. We encourage professional and personal development and support exchange programs between our various sites to benefit from the collective knowledge of our 350+ PhDs around the globe.

联系方式

  • 公司地址:上海市奉贤区化学工业区舜工路69号