Lilly Sr. QA Specialist - Batch Release in Suzhou Manufacturing-苏州, China
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 35,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.
The batch disposition QA assures patients safe and drug products efficacious through effective quality oversight of the site.
The batch disposition QA is responsible for disposition of finished products. The batch disposition QA provides guidance to process team members for batch related issues, such as non-conformance investigations, issue resolution and other batch disposition activities.
执行成品的批处理，确保高质量的产品及时的被释放到市场上。 Perform batch disposition of finished products to ensure high quality medicine is released to market in a timely manner.
在和批次处理相关的质量问题上，领导，指导或者辅导生产或者支持人员。 Lead, mentor and coach operation and support personnel on quality matters associated with the batch / batch disposition.
为包装区域提供指导，确保质量系统的有效性，符合GMP要求。 Provide guidance in package area to ensure effectiveness of quality system and GMP compliance.
为工厂内部自检、外部质量审计、验证以及产品召回等质量管理活动提供支持。 Provide support to quality management activities, which may include self-inspection, external quality audit, validation, and product recall.
了解持续稳定性考察结果，确保结果符合法规要求和质量标准。 Understand the results of on-going stability studies to ensure the results meet regulatory requirements and specification.
能够有效的审核或批准文件，保证满足产品质量的要求（如：偏差，规程，方案，质量标准，变更控制）。 Be able to effectively review or approve documents to ensure quality attributes are met (e.g., deviations, procedures, protocols, specifications and change controls).
参与到六西格玛项目或者流程改进项目中，提升批处理的效能。 Participate in Six Sigma project or process improvement initiatives to improve productivity within the batch disposition.
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.
至 少 5 年的 QA/QC 工作经验 At least five years of working experience in QA/QC
熟练使用电脑 Proficiency with applicable computer systems
较强的口头和书面沟通技巧 Demonstrate strong oral and written communication skills
较强的人际沟通和团队协作能力 Demonstrate interpersonal skills and ability to work as a team
较强的根本原因分析和解决问题的能力 Root cause analysis and troubleshooting skills
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
能用英语听、说、读、写 Capable of listening, speaking, reading and writing in English
独立工作或者团队协作解决问题 Ability to work independently or as part of a team to resolve issues
拥有礼来的偏差管理和变更控制的经验,优先考虑 Previous experiences with Lilly deviation and change management , preferred
较强的技术写作和沟通技巧 Technical writing and communication skills
执业药师优先考虑 License pharmacist, preferred
有可能需要加班 Overtime may be required
有可能需要在非工作时间协助解决问题 May be required to respond to operational issues outside of core business hours/days
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