南京招聘

Today Lonza is a global leader in life sciences. We are more than 15,000 employees in more than 100 locations around the world. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

As Senior QA Validation Specialist, you will represent the QA Validation department and act as a liaison between QA Validation and its internal and external customers. You also need to utilize your knowledge and technical experience to complete a variety of tasks and to ensure all critical GMP equipment and systems are validated and maintained in compliance with user requirements, process parameters and global regulatory guidelines.

Key responsibilities:

• Monitor day-to-day Qualification & Validation activities in accordance with approved Policies/SOPs / Plan for API manufacturing facilities and equipment.
• Participate in review and approval of series of Qualification documents (URS/ QP/RA and DQ/IQ/OQ/PQ plans / Reports, including handling of any discrepancies, deviations and changes during qualification and validation.
• Support / participate in Site Validation & Qualification Maintenance Program to ensure GMP facilities and equipment are continuously maintained in a validated state.
• Actively co-ordinate with internal and external validation resources to achieve department / project goals
• Perform change control assessments for GMP equipment and associated validation activities to ensure compliance with regulatory requirements.
• Review and approve the CRs and DRs related to equipment and facilities.
• Participate in Customer / Agency Audits and Inspections as required
• Participate in on-job training program for staff
• Any other tasks as and when assigned by supervisor

Key requirements:

• Bachelor’s Degree with a field of chemical or pharmaceutical engineering discipline preferred.
• Solid experience in Qualification and validation in API manufacturing environment with strong knowledge of FDA, EMA and Chinese GMP regulation requirements regarding qualification and validation.
• Strong multi-task management & independency ability.
• Good communication skills and self-motivated.
• Business fluent at English preferred.

Every day, Lonza's products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

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.