Associate-QA FUME in Suzhou

Job Description

Join American pharmaceutical leader Eli Lilly and Company, currently hiring Associate-QA FUME in Suzhou, Apply Lilly careers in Suzhou Shanghai.


Position : Associate-QA FUME

Location : Suzhou, China

Job id: R-34346


Job Details

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.FUME QA为包装区域提供质量支持,维护质量系统的运作和GMP合规。The FUME QA provides support to package area, while maintaining quality systems and GMP compliance. FUME QA主要支持包装区域的FUME和IT部门,对跟质量相关的偏差调查,变更控制,设计,建设,设备和计算机系统,文件升版,GMP图纸,验证,试车和确认等提供支持。The FUME QA primary support FUME and IT function group, provide assistance and guidance in non-conformance investigation, change control, design, construction, equipment and computer systems, procedure revisions, GMP drawings, validations, and commissioning and qualification. FUME QA 的职责对于保证GMP合规和各种法规审计的准备等至关重要。The FUME QA position is essential for maintaining GMP compliance and in the preparation for general inspections by various regulatory agencies.                                                        主要职能:Key Objectives/Deliverables: 以下职能主要支持礼来苏州湖东包装工厂。The following objectives are mainly related to Lilly Suzhou Pharmaceutical East Lake Packaging.影响和监督包装区域的设车验证和计算机系统的验证工作Influence and oversee the Commissioning and Qualification (C&Q) and Computer Systems Validation (CSV) of GMP assets in package area.影响和监督包装区域的维护/校验活动Influence and oversee maintenance / calibration programs within package areas, including benchmarking with other sites.支持包装流程团队的工作, 和包装区域及支持部门进行影响沟通。Support process team projects and communicate impact to package areas and associated support groups.批准关键报警的审计追踪和业务审核。Perform approval for critical alarm audits and business reviews.审核和批准GMP文件和图纸。Review and approve GMP documents / drawings.辅导和指导质量工程的支持工作,包括工艺知识,问题解决,项目管理和文件设计。Coach and mentor others in aspects of fundamental quality engineering support, include process knowledge, problem solving, project management and documentation design.参与到自检和法规检查中。Participate in self-led and agency inspections.评估任何GMP相关的事件对SISPQ的影响,对偏差进行初始的定级,支持调查。Evaluate potential SISPQ impact for any GMP-related incident, perform initial levelling of non-conformances and support the investigations.基本要求:Basic Requirements: 本科及以上学历,药学化学或相关学科Associate degree or above, major in pharmaceuticals, chemistry or related sciences *至少1年的GMP经验At least one-year experience in GMP facility完成/维护CSV的培训Become / remain certified on CSV (computer system validation)熟练使用电脑系统Proficient with computer systems较强的沟通和人际技巧Demonstrate strong communication and interpersonal interaction skills能用英语听、说、读、写Capable of listening, speaking, reading and writing in English其他要求:Additional Preferences: 有礼来的偏差管理和变更控制管理的经验Previous experiences with Lilly deviation and change control management有GMP生产,工程,QC, QA 或者TSMS的工作经验Experiences in Production, Engineering, QC, QA, or TSMS较强的技术写作和书面沟通技巧Demonstrated technical writing and written communication skills执业药师优先考虑License pharmacist, preferred其他信息:Other Information: 有可能加班Overtime may be required有可能在非工作时间支持团队May be required to respond to operational issues outside of core business hours / daysEli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.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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