QA Specialist

At Elanco (NYSE: ELAN) – it all starts with animals!

As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets.

We’re driven by our vision of ‘Food and Companionship Enriching Life’ and our approach to sustainability – the Elanco Healthy Purpose™ – to advance the health of animals, people, the planet and our enterprise.

At Elanco, we pride ourselves on fostering a diverse and inclusive work environment.

We believe that diversity is the driving force behind innovation, creativity, and overall business success.

Here, you’ll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights.

Making animals’ lives better makes life better – join our team today!

Key Responsibilities:主要职责：

Primary Function基本职能

To assist QA Manager to conduct QA oversight within Wusi site, review and approve GMP documents to ensure that all aspects of manufacturing activities comply with cGMP, legal and regulatory requirements and with the headquarters Quality Standards.

协助QA经理在五四工厂进行QA监督，审核和批准GMP文件，以确保生产活动的所有方面符合cGMP法律法规要求和Elanco动物保健质量标准。

Primary Accountabilities/Responsibilities 基本职责


* Manage and maintain deviation and CAPA management comply with global procedures and GMP guideline, ensure deviation and CAPA activities disposed timely.


* 管理和维护偏差和CAPA管理符合全球程序和GMP准则，确保偏差和CAPA活动得到及时处理。


* Manage and maintain change control management comply with global procedures and GMP guideline, ensure change control activities disposed timely.


* 管理和维护变更控制符合全球程序和GMP准则，确保变更控制活动及时进行。


* Manage and maintain deviation, change control and CAPA modules in computer system.


* 管理和维护计算机系统中的偏差，变更和CAPA模块。


* Manage and maintain reprocess and rework management comply with global procedures and GMP guideline, ensure reprocess and rework activities disposed timely.


* 管理和维护再加工和返工管理符合全球程序和GMP准则，确保再加工和返工活动及时处理


* Review Validation/Qualification Protocol and Report, draft and review quality risk assessment.


* 审核验证/确认方案和报告，起草和审核质量风险评估


* Act as a partner with the production department to review related procedures, participate in projects and related investigation.


* 与生产部一起审查相关程序，参与项目和相关调查。


* Perform review of GMP related documents (formulation and pesticide batch records, raw material analytical record, etc.) to ensure batch release timely.
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