上海招聘

Responsibilities:

1)  Ensure that regulatory and internal ESH requirements are met or exceeded at all times.

2)  Ensure that all production activities comply with GMPs and regulatory requirements.

3)  Maintain annual, monthly, weekly and daily production plan, and guide and lead production staff to implement the plan to achieve the production order objectives.

4) To improve the level of parameter control and production conditions to ensure product quality.

5)  Ensure that needed master manufacturing documents, SOPs, procedures, etc. are created in a timely manner; review existing or newly created documents, where needed revise existing documents or initiate or author new documents.

6)  Improve the management procedures of manufacturing to approach higher standard of safety and cleaning.

7)  Cooperate with EHS on safety and environmental protection work. To ensure production operations follow strictly procedures, SOPs and other regulations on safety and environmental protection.

8)  Maintain a plan to improve and optimise the production capabilities. The plan follows the strict logic that matters that are required for safety or GMP are done first, then efficiency improvements and lastly capacity and capability enhancements, always providing the need exists and funds and resources are available for those activities.

9)  Based on new chemical project requirements, introduce new equipment and safety devices to meet the process requirements.

10)  Improve the safe and functional status of equipment and utility, so as to ensure that the requirement of SOPs, regulations, and laws can be fulfilled.

11)  To implement and improve current system for qualification documentation, including but not limit to URS and acceptance of equipment, process and cleaning validation.

12)  Review and inspect URS, design concept, GMP files (DQ, IO, OQ, and PQ) of project equipment implementations. 

13)  Employ, guide, discipline and train employees in production with the local regulations and SOPs, to improve the operational skills and knowledge.

14)  Apply the internal appraisal system, utilise positive incentive mechanism and guide the staff positively to achieve their best.

15)  Raise the level of professionalism of the employees and their understanding of the relevant matters.

16)  Ensure balanced work-life by distributing work and delegate tasks where necessary.

17)  Interacts with the other department heads to understand their requirements and needs and respond to it.

Requirements:

   Education:  Degree in Chemistry or Chemical Engineering. (Bachelor Degree at least) .  

   Experience: Minimum 8 years of working experience in pharmaceutical/API industry in relevant leadership and managerial role. Experience in GMP audit by medical authorities and customers.          

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.