Sr QA asscociate

We’re looking for people who are determined to make life better for people around the world.

1. 为湖东包装工艺流程团队提供secondary loop QA 支持。 包括基于需要，定期参与流程团队活动， 为任何GMP相关的事件评估潜在的质量影响并支持调查， 指导并发展Primary loop 和Zero loop QA， 参与自检和/或官方检查，以及复核和/或审核GMP文件（例如：不符合项，规程，方案，和变更控制）
Provide secondary loop QA support across packaging process team for East Lake Packaging， including：

Maintain a regular presence and participation on process teams as needed; support and maintain a regular presence on the floor during production activities; evaluate potential Quality impact for any GMP-related incident and support the investigations; act as coach and mentor to primary and zero loop QA personnel; participate in self-led and/or agency inspections; review and or red-line GMP documents (example: Non-conformances, procedures, protocols, and change controls).

2. 支持工艺设计、确认和验证，包括：
Support the process design, qualification and validation which includes:

- 支持审核和/或批准用户需求，技术标准，确认包，工艺流程文件和其他文件

Support review and / or approval of User Requirements, Technical Specifications, Qualification packages, Process Flow Documents, and other documentation

- 确保设计、确认、验证文件和记录符合GMP要求

Ensuring design, qualification, validation, and documentation is in compliance with GMPs,

- 如有需要，参与确认的执行，包括工厂接受测试，安装确认，运行确认，性能确认和工艺验证

Participating in qualification execution, including FATs, IQ, OQ, PQ, and process validation, as required

3.支持产品放行，包括审核批记录、出具产品合格证明、维护成品质量标准、维护或复核成品主数据，包括Darwin, PMX , SAP和ACRN以及执行产品放行相关变更的执行步骤等。

Support product batch release， including: review batch record, issue product conformity certificate, maintain finished product quality specifications, maintain and review finished product master data, including Darwin, PMX, SAP and ACRN, perform implementation steps for changes related to product release.

基本要求：

1. 具有药学、化学、生物学或相关专业本科及以上学历。

Have an educational qualification of an undergraduate course or above in pharmacy, chemistry, biology or related sciences.

2. 熟练使用电脑

Proficiency with applicable computer systems

3. 较强的口头和书面沟通技巧

Demonstrate strong oral and written communication skills

4. 较强的人际沟通和团队协作能力

Demonstrate interpersonal skills and ability to work as a team

5. 较强的根本原因分析和解决问题的能力

Root cause analysis and troubleshooting skills

6. 关注细节，能够维护质量系统的能力

Demonstrate attention to detail and ability to maintain quality system

7. 能用英语听、说、读、写

Capable of listening, speaking, reading and writing in English

Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

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