上海招聘

• 1. Support the implementation and maintenance of the Quality System of the site in accordance with ICH Q7 and other relevant regulations.
• 2. Provide QA oversight for utility systems, warehouse, production equipment to ensure GMP practices, compliance and SOPs implementation.
• 3. Review / Approve Executed Batch Record (manufacturing, analytical), equipment qualification reports, validation documents, change control, deviations; provide QA support for deviations, CAPA, change control, internal audits, and assisting in the preparation and smooth execution of audits from Health Authorities, Corporate, Customers Self Inspections.
• 4. Support reporting and trending of Quality KPIs on periodic basis as required.
• 5. Identify and execute Continuous Improvement initiatives, including workflow processes to improve productivity.
• 6. Perform any other duties as assigned by Supervisor according to compliance and business needs.

• 1) Minimum 3~5 years working experience in quality department with good understanding of quality standards and  requirements  (e.g. FDA, NMPA, EMA, ICH Q7) and production processes. Working experience in a GMP environment in pharmaceutical/API industry.
• 2) Experienced in handling deviations, change control, manufacturing/analytical batch record review.
• 3) Fast learner with ability to adapt to changes, and with continuous improvement mindset. Able to write and communicate well in English (intermediate level) and in Chinese language.
• 4) Good knowledge of Process Validation.

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.