上海招聘

Position Title: QA Manager, Elanco External Manufacturing, China

Location: Shanghai

Supervisor: Senior QA Manager

Position Brand Description:

Elanco is a global research-based company that develops and markets products to improve the health and production of animals in more than 100 countries, and is an exciting division of Eli Lilly and Company. Elanco products enhance animal health, wellness, welfare and performance to help the food industry produce an abundant supply of safe and affordable food. With the acquisition for Novartis Animal Health(NAH) , Elanco is becoming the No 2 animal healthcare company globally.

The QA role is responsible for providing quality oversight for external manufacturing including contract Manufacturing operations and suppliers in the People’s Republic of China. The QA role performs quality visits, provides assistance and guidance in deviation investigations, change control proposals, procedure master formula revisions, annual product reviews, stability trending, customer complaints and validation of the manufacturing processes. The QA position is essential for maintaining cGMP compliance and in the preparation for inspections by various regulatory agencies to Elanco’s products.

Key Objectives/Deliverables:

• CMO governance:

• Performs quality visits at contract manufacturers to provide quality oversight, such as changes & deviation handling, manufacturing instruction reviewing etc
• Perform site batch release for Elanco contract manufacturing products
• Prepare and maintain the quality agreements
• Provide quality leadership on the manufacturing floor
• Support production floor operations in validation activities
• Ensure deviations, out-of-specification or out-of-trend data are investigated adequately
• Facilitate periodic audits/inspections of production areas and ensure the audit outcomes are responded adequately
• Investigate customer complaints
• Support annual product reviews
• Assist Quality team Leader of EEM China to maintain Quality System of EEM China

External suppliers governance

• Performs quality visits at external suppliers to provide quality oversight, review changes, participate in complaint investigations, and other important quality activities
• Prepare and maintain the quality agreements
• Perform supplier governance with risk based approach that also is compliant with recognized industry quality standards such as ICH, ISO etc
• Ensure changes in suppliers are well communicated and assessed
• Review investigation on the out-of-specification or out-of-trend data
• Facilitate periodic audits/inspections of production areas and ensure the audit outcomes are responded adequately
• Investigate customer complaints

Maintain global supplier management network for EEM China

Minimum Requirements:

• Two years above of experience in drugs/APIs/vaccines QA, technical or production
• Ability to work independently

Capable of speaking, writing, and reading English fluently

Additional Preferences:

Demonstrated knowledge of cGMPs, quality systems and pharmaceutical supply chain.

Good understanding of industry standards such as Pharmacopeia, ISO standards, etc.

Education Requirements:

Bachelor’s degree or above, majored in pharmaceuticals, biochemistry or related science

Other Information:

Occasional travel, approximately 20% working time per year.

Elanco成立于1954年，在全球90多个国家提供全面的产品和技术服务，致力于改善动物健康和食品动物生产水平。Elanco重视科学研究和日常运营的创新，竭力为全球5800多名员工营造协作互助的工作环境，与客户一起致力于提高全球食品安全意识，加强建立人与动物间的紧密联系并提供帮助。Elanco全球总部和研发中心位于印第安纳州格林菲尔德。
Elanco在全球70个国家开展业务，其中包括16个工厂和14个专注于动物保健（伴侣动物、食品动物、疫苗、驱虫药、酶制剂、疾病诊断和水产）的研究中心。