上海招聘

QA Manager-Supplier Audit

Job description
1.Implement the audits to Chinese API / Intermediates suppliers, according to cGMP requirement as per ICH guidelines, also as per Lupin SOP/regulations.
2. Auditor should plan the audits as per the schedule, finish the audit reports in due time.

Required professional background
1. Graduate / Post graduate, Pharmaceutical or related discipline
2. 6 years experiences in manufacturing / Quality Assurance in API manufacturing facility.
3. 3 years in auditing department of FDA/EU GMP certified pharmaceutical company, candidate working in auditing department of multinational pharmaceutical group is preferred.

Required Capabilities
1. Proficient in English writing, reading, listening and speaking, auditor needs to have free communication with corporate QA.
2. Good knowledge of cGMP/ICH guideline, Excellent attention to detail with the ability to identify the root cause of problems
3. Good team player
4. Good organizing and communication ability
5. Good time management skill, sense of urgency, precision and reliability
6. Be able to work under pressure

公司简介：

鲁宾有限公司是一家以创新为主导，在世界范围内为发达国家和发展中国家提供广泛的高品质，低价位的仿制及品牌制剂和原料药的跨国公司。
在鲁宾，我们努力通过在世界范围内为患者提供可负担、可获得的药品，为人们营造健康的生活。我们致力于发现、研发和使创新药物商业化来满足未能被满足的医疗需求。
当成为世界上最大的结核药生产商时，鲁宾首次得到了认可。多年来，公司已提升了价值链，不仅在中间体和原料药方面有所建树，也充分利用其优势在全球范围内建立起制剂业务，足迹遍布美国、印度、日本、澳大利亚、英国、德国、独联体等。

我们的优势：

-完全综合性制药公司
-在仿制药、新化学实体、新型给药系统、新生物实体、研究等领域建立了强大的科研基地
-获得国际管理机构批准的世界级的GMP标准生产设施，包括美国，
-以坚实的科技和专业知识为依托，提高产品科技含量，生产出更具创新性的产品
-强有力的全球足迹：美国、印度、日本、澳大利亚、英国、德国、独联体等
-大型动态营销队伍和强大的分销网络
联系人: Sharon Liu 邮箱: lupinshanghai@gmail.com 网址: www.lupinworld.com
联系电话:+862164329500

Company Profile:
Lupin Limited is an innovation led transnational pharmaceutical company producing a wide range of quality, affordable generic and branded formulations and APIs for the developed and developing markets of the world.

At Lupin, we strive to help people lead healthier lives through delivering affordable and accessible medication to patients across the world. We are engaged in discovering, developing and commercializing innovative medicines that satisfy unmet medical needs
Lupin first gained recognition when it became one of the world’s largest manufacturers of Tuberculosis drugs. Over the years, the Company has moved up the value chain and has not only mastered the business of intermediates and APIs, but has also leveraged its strengths to build a formidable formulations business globally with strong global foot prints in US, India, Japan, Australia, Europe, South Africa, Philippines, CIS etc.
Our Strengths are:
1.Fully Integrated pharmaceutical company
2.Strong Research Base in the areas of Generics, New Chemical Entity, Novel Drug Delivery Systems, New Biological Entity, research
3.World Class GMP Compliant Manufacturing Facilities approved by international regulatory agencies including US,FBA,MHRA etc.
4.Sound Technology Base and expertise to scale up technology to deliver innovative products
5.Strong Global Footprint : USA, India, Japan, Australia, UK, Germany, CIS
6.Large Dynamic Sales Force and Robust Distribution Network

Contact Person: Sharon Liu Email: lupinchina@126.com
URL: www.lupinworld.com Tel:+862164329500