高级生产工艺工程师
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:2020-11-03
- 工作地点:上海-奉贤区
- 招聘人数:1人
- 工作经验:8-9年经验
- 学历要求:硕士
- 语言要求:英语
- 职位月薪:30-40万/年
- 职位类别:药品生产/质量管理 化工技术应用/化工工程师
职位描述
Responsibilities:
· Introduction of new process into production from customer and R&D centre. Organize assessment of new process on safety and compliance perspective.
· Propose the modification of equipment and facility for new process. To ensure the adaptation of safety, process parameters control and GMP compliance.
· Be charge of change control draft, master manufacturing records preparation and relevant records.
· In charge of new process training to operators and engineers, to ensure all operational activities of production in good compliance status.
· Review executed records and finalize the release records with quality department, to meet expectation of customers and regulations.
· In charge of investigation of deviations on materials, process and equipment, to find out the root cause, with method of fish bones mapping, 5 why, etc.
· Analysis technical data of process, draft the project progress report, to ensure the process or product manufacturing is in good understanding from customers and technical departments.
· Involve process validations and cleaning validations.
Requirements:
· Master degree in Science, Chemistry, Pharmacy or Chemical engineering.
· Minimum 5 years of working experience in pharmaceutical company.
· Good written in English. Able to communicate with oral English.
· Above 3 years GMP practical experience. Good GMP sense.
公司介绍
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