南京招聘

At Lonza, we invest in great people. We encourage our employees to challenge themselves and we offer an environment that fosters creativity and success. Headquartered in Basel, Switzerland, we operate production, R&D, and business sites around the world, including Europe, North America, and Asia.

Our vision:

We strive to be the leading supplier using science and technology to improve the quality of life.

Our mission:

We work with passion, using advanced technologies, to transform life science into new possibilities for our customers.

Do you want to help us as we shape the future of this great organization?

  

轮班QA

  

  

Job Responsibilities:

  

• 对现场生产活动进行监督（例如关键工艺步骤、开放操作），及时提醒和纠正操作人员的不合规操作，增强生产操作员的GMP意识，确保现场生产活动的GMP符合性。

• 抽查生产现场相关文件、记录，确保生产记录符合数据完整性的要求。对生产准备的打码空白记录进行确认并加盖QA章。

• 对生产现场进行符合性检查，确保现场的各种标识、仪表、设备状态等符合GMP 要求。

• 定期对厂房的清洁状况和其他设备/设施的维护状况进行检查、确保其状态良好，对洁净间的清场效果进行抽查，及时与当班生产负责人及时沟通发现的问题并敦促其解决。

• 审核生产部门的相关操作规程\指引，协助项目QA审核批记录、跟进偏差调查和生产现场纠正措施的实施情况。

• 协助清洗QA，在夜班或节假日放行清洁后软管、洁净间及需要由QA目视检查的小件物品

• 与项目QA协作，跟进生产指令的签发和相关文件的打印和发放。

• 对于内部审计或外部审计产生的缺陷项，现场确认改进措施的实施情况。

                

Requirements:

  

• 本科学历，制药、化工相关专业

• 制药化工行业2年以上质量管理工作经验

• 熟悉cGMP, ICH Q7等，熟悉原料药的质量管理体系

• 大学英语4级以上、口语流利，熟练应用office软件

• 积极主动，优秀的沟通协调能力，优秀执行力

关于龙沙
在龙沙，我们将技术创新与卓越生产及工艺完美结合，助力我们的客户在保健、防腐与保护领域实现他们的研发成果。

我们是全球制药、生物技术与特殊成分市场的优秀合作伙伴。 我们致力于疾病预防，并通过助力客户推出创新药物用以辅助治疗或治愈一系列的疾病，促进我们的世界更健康。同时，我们也提供广泛的微生物控制解决方案，共同营造和维护健康的环境。

1897年，龙沙诞生于瑞士的阿尔卑斯山脉地区，迄今拥有 120 个生产基地和办事处，遍布全球超过35个国家。 我们拥有约15,500名全职员工，由他们组成的高效团队及每一名员工都为我们的业务和所在地区及国家做出意义非凡的改变。2019 年，公司销售额达59亿瑞士法郎，核心业务的息税折旧摊销前利润（EBITDA）达16亿瑞士法郎。更多详情，请访问 *************。


About Lonza
At Lonza, we combine technological innovation with world class manufacturing and process excellence. Together, these enable our customers to deliver their discoveries in the healthcare, preservation, and protection sectors.
We are a preferred global partner to the pharmaceutical, biotech and specialty ingredients markets. We work to prevent illness and promote a healthier world by enabling our customers to deliver innovative medicines that help treat or even cure a wide range of diseases. We also offer a broad range of microbial control solutions, which help to create and maintain a healthy environment.
Founded in 1897 in the Swiss Alps, Lonza today operates in 120 sites and offices in more than 35 countries. With approximately 15,500 full-time employees, we are built from high-performing teams and of individual employees who make a meaningful difference to our own business, as well as the communities in which we operate. The company generated sales of CHF 5.9 billion in 2019 with a CORE EBITDA of CHF 1.6 billion. Find out more at ************* and follow us on Twitter @LonzaGroup or Facebook @LonzaGroupAG.