Sanofi
Pharmaceutical
QAOps&BatchReleaseLead
Neural analysis suggests this role is
optimal for Lead candidates.
“QA Ops & Batch Release Lead at Sanofi. Skills: Quality assurance, Batch release, Regulatory compliance. Ensure activities comply with regulatory requirements. Ensure compliance with GMP”
Industry & Context.
Analyze complex data; Identify trends; Identify issues; Identify solutions; Problem identification; Corrective action implementation
What They're Looking For.
Must Have
2 years pharmaceutical QA experience, Knowledge of GMP, Knowledge of quality assurance principles
What You'll Do.
Ensure activities comply with regulatory requirements
Ensure compliance with GMP
Conduct audits of production processes
Collaborate with production
Manage quality-related issues
Monitor quality performance metrics
Implement corrective actions
Lead root cause analysis investigations
Implement preventive measures
Participate in audits and inspections
Develop risk management strategies
Foster quality culture
Oversee batch release process
Oversee review of batch records
Ensure batch release activities comply with GMP
Conduct risk assessments for batch release
Implement mitigation strategies for batch release
Coordinate actions across teams for timely release
Investigate batch release issues
Resolve batch release deviations
Evaluate temperature excursions
Collaborate with regulatory affairs
Monitor batch release performance metrics
Implement continuous improvement initiatives
Attend quality alert meetings
Determine batch handling
Represent factory in CoP
Ensure local communication
Conduct on-site complaint investigations
Coordinate investigation reports
Request corrections when GMP rules are not respected
Prioritize quality and compliance goals
Approve actions during Quality Alert meeting
Advise on complaint investigation
Perform other duties assigned
How You'll Work.
Team & Collaboration
Cross-functional teams; Production department; Quality Control; Regulatory affairs
Communication Scope
Verbal communication; Written communication
Full Job Description
**Job Information 职位信息** **Job title职位名称: QA Ops & Batch Release Lead** • Location工作地点： Shenzhen, China 中国深圳 • % Remote working and % of travel expected 远程办公和出差的概率：N/A • Job type工作类型: Full time全职 • Site/Unit 区域/事业部：Beijing Site/ M&S China北京工厂/中国制造与供应事业部 **About the job 工作职责** Our Team我们的团队： 制造与供应事业部包含以3个全球事业部为基础的制造平台，以及质量、供应商、精益战略等支持部门，致力于用优异的战略和工具制造优质的药品并传递到患者手中。 关于我们的团队： 赛诺菲作为一家全球领先的创新医药健康企业，深圳工厂专注于流感疫苗的全流程生产制造及进口疫苗的本地包装，服务于中国市场。工厂位于深圳市坪山区锦绣东路25号赛诺菲生命科学园区。 我们的质量运营（QA Ops）与PCU团队秉承赛诺菲"Take the Lead"价值观，是工厂质量与卓越运营的核心支柱： Aim Higher - 我们专注于最重要的质量目标，设定高标准并以紧迫感推进工作，从挫折中学习以实现更高绩效 Act for Patients - 我们绝不在诚信上妥协，消除障碍并与他人合作，为患者走得更快更远 Be Bold - 我们承担深思熟虑的风险，抓住机遇，超越可能的边界来加速我们的科学进步 Lead Together - 我们建立信任，围绕共同目标开放合作，庆祝集体胜利并培养归属感 团队致力于质量管理的卓越运营，通过放行管理、产品质量回顾（PQR）及生产质量运营等核心职能，确保质量体系持续稳健运行，践行"追寻科学奇迹，焕发生命光彩"的使命。 The M&S division encompasses manufacturing platforms built on 3 global business units, along with supporting functions including Quality, Supply, and Lean Strategy. It is dedicated to manufacturing high-quality medicines and delivering them to patients through outstanding strategies and tools. About Our Team: As a globally leading innovative biopharmaceutical company, Sanofi's Shenzhen site focuses on the end-to-end manufacturing of influenza vaccines and local packaging of imported vaccines, serving the Chinese market. The site is located at Sanofi Life Sciences Park, No. 25 Jinxiu East Road, Pingshan District, Shenzhen. Our Quality Operations (QA Ops) and PCU team upholds Sanofi's "Take the Lead" values and serves as a core pillar of quality and operational excellence at the site: • Aim Higher – We focus on the most critical quality objectives, set high standards, and drive our work with a sense of urgency, learning from setbacks to achieve higher performance. • Act for Patients – We never compromise on integrity, remove obstacles, and collaborate with others to go further and faster for patients. • Be Bold – We take calculated risks, seize opportunities, and push beyond the
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