M&S-China EM&S QA Manager-Shanghai
Sanofi
Estimated pay: Est. $19–$29/hr (market estimate, not employer-stated)
Shift: Full time
Job title 职位名称 : China EM S QA Manager Location工作地点： Shanghai 上海 About the job工作职责 We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started? Main responsibilities 职责描述： 1. 合同生产监督Contract Production Supervision 在委托生产期间实施驻厂，并对整个生产管理和质量管理过程进行现场指导和监督，确保生产工艺、质量标准等各方面均符合法规要求Perform person in plant (PiP) in the Contract Manufacturing Enterprise during the entrusted manufacturing of drugs and carry out on-site guidance and supervision over the whole process of production management and quality management to ensure that the production process, quality standards etc. comply with regulatory requirements 确保对物料（原料药、辅料和包装材料）进行入厂质量控制，并定期对CMO的检验结果进行抽查复核，确保相关物料符合药品要求和法律法规标准Ensure management of Incoming Quality Control of materials (API, Excipients and Packing materials), and regularly conduct spot check review of Incoming Quality Control results of CMO to ensure that the relevant materials meet pharmaceutical requirements and legal Specifications 共线生产线的质量风险管理：确保为受托产品制定并实施交叉污染控制措施，保障产品质量安全Quality risk management of co-production line: Ensure the formulation and implementation of cross-contamination control measures for the entrusted product, and to ensure product quality safety 支持QAI定期对合同生产企业质量管理体系进行现场检查，确保持续符合法律法规要求Support QAI regular on-site inspection of the QMS of Contract Manufacturing Enterprise to ensure that it continues to comply with legal requirements 作为MAH质量部门与外部CMO之间的联络人，及时传达公司的质量要求和期望；与CMO保持良好沟通，及时掌握其供应链的变化；建立有效的信息反馈渠道，能够快速响应潜在问题As a liaison between the MAH quality department and the external CMO, convey the company s quality requirements and expectations in a timely manner; Maintain good communication with CMO to keep abreast of changes in their supply chain in a timely manner; Establish an effective information feedback channel to quickly respond to potential problems 2. 主要物料、中间产品及成品的取样分析Sampling analysis of key materials, intermediates and finished products 确保开展抽样分析，包括定期抽样分析以及因重大偏差、重大变更或显著不良趋势而触发的抽查分析The conduct of spot analysis shall be ensured, including regular spot analysis and the spot inspections triggered by significant deviation, major change, major adverse trend 确保质量控制实验室的合规性，并监督合同检验全过程 Ensure the compliance of the quality control laboratory and supervise the whole process of Contract Analysis 3.产品放行Product release 确保所有待上市产品在放行前均经过严格审核，包括批次分析记录、批生产记录、偏差处理、OOS（超标结果）调查等，以实现产品质量目标，确保产品符合GMP要求和注册标准Ensure that all products to be marketed have been strictly reviewed before release, including batch analysis records, batch production records, deviation handling, OOS investigation, etc., to achieve the product quality target and comply with GMP requirements and registered specification 药品追溯基本信息的维护与关联关系上传Maintain product traceability basic information and upload aggregation information file 必要时，质量负责人（质量授权人）的转授权人进行相关工作if needed, as the delegation of Quality responsible person (Qualified person to perform the relevant work 对退货产品 / 不合格产品进行评估并做出决定，负责不合格品的监督销毁 Assess and make decision for the return goods/ rejection, responsible for the supervision of rejected materials destruction 4.其他活动Other activities 审批验证相关文件Review and approve validation related documents 跟进已放行/分销产品和货架期结束前长期稳定性研究中确认的超出规格(OOS)结果，并协调任何相关的监管行动 For the follow up of confirmed Out of Specification (OOS) results on released/distributed product and on long term stability studies that occur prior to end of shelf life and coordinating any related regulatory actions 支持识别、评估、控制和沟通涉及职责范围内组分、原材料和成品药物的风险 To support identification, assessment, control and communication of risks involving components, raw materials, and finished pharmaceuticals within scope of responsibility 确保偏差和变更控制活动得到一致且及时的管理 To ensure that the deviation and change control activities are consistently and timely managed 确保实施和评估纠正和预防措施以解决系统性问题 To ensure implementation and evaluation of corrective and preventive actions to address systemic issues 跟进（潜在的）可报告事件 For the follow up of (potential) reportable events 支持组织职责范围内CMO（委托生产商）的审计管理，以及与全球审计和供应商管理运营部(SMO)合作执行审计 To support the organization of an audit management program of CMOs within scope as well as audit program execution in cooperation with global audit program and Supplier Management Operations (SMO) 确保准确、及时且符合GMP要求地实施职责范围内CMO生产的技术产品投诉的生产调查 Ensure accurate, timely, and GMP-compliant implementation of manufacturing investigations for technical product complaints from CMO production within the scope of responsibility 支持实施自检和持续改进工具 To support the implementation of self-evaluation and continuous improvement tools 负责职责范围内产品的产品质量回顾(PQR)的撰写 P