# Manufacturing QA Associate Manager 包装质量QA副经理 at Roche

Roche is hiring a Manufacturing QA Associate Manager 包装质量QA副经理 in Shanghai, China. Level rates it Little AI ●○○○; you can [apply on Roche](https://jobsbylevel.com/go/0fef09d8-9a43-4f0a-8894-21623794a6e9?utm_medium=ai-agent).

AI Level 1, AI centrality 36 out of 100. Shanghai.

## Details

- Company: [Roche](https://jobsbylevel.com/companies/roche)
- AI level: AI Level 1 (score 36 out of 100)
- Location: Shanghai
- Posted: November 4, 2026
- Apply: https://jobsbylevel.com/go/0fef09d8-9a43-4f0a-8894-21623794a6e9?utm_medium=ai-agent
- Free CV review for this job: https://jobsbylevel.com/cv-review?job=manufacturing-qa-associate-manager-qa-at-roche-63c98e

## Description

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters. The Position Quality Oversight / 质量监管 1.1 Collaborate with key stakeholders including manufacturing operations, supplier quality, quality systems and Planning; provide Quality oversight in repackaging products and IMP materials life cycle and the E2E process. 与质量利益相关方共同协作，利益相关方包括并不仅限于生产运营、供应商质量、质量系统及计划，在进口分包装产品及临床试验物料生命周期中端到端的过程实施质量监管。 As per the business arrangement, the scope of quality oversight should cover the quality activities in all related areas including warehouse operation and packaging plants. 根据业务安排，监管区域应覆盖包括仓库运营和包装区域所有相关区域的质量活动。 Manage and oversee frontline QA activities of repackaging products and IMP products in plants. 管理进口分包装和临床试验产品的现场QA活动。 Manage of sampling process for repackaged products 管理对进口分包装产品抽样流程 Perform oversight of Specification, process and product monitoring for repackaging products 对进口分包装产品的质量标准，工艺与产品监测实施监督 Perform oversight of stability program for repackaging products 对进口分包装产品的稳定性项目实施监督 Connection with Global, take role as quality role across the repackaging product life-cycle management. 与总部联系，在进口分包装产品生命周期管理中做好质量角色 Execution of frontline QA activities in plants and warehouse 执行车间和仓库的现场QA活动 Acknowledge the live status in production area according to the DPS and follow up with actual excursions against the DPS, identify the potential risks and take preventive action. 根据生产计划，实时了解生产动态, 对实际生产情况与生产计划的偏离进行现场跟进，辨识潜在的质量风险，进行提前预防. Join Tier meeting in production and warehouse or other Tier meetings 参加生产部和仓库例会或其他层级会议 Perform batch record review 执行批次记录审核 Enabling real-time problem solving with production and warehouse team 促进与生产和仓库团队共同实时解决问题 1.2 Implement repackaging and additional labeling IMP product-related batch release process 对进口分包装产品和临床试验药品重贴标的批次放行相关流程实施 Ensure on-time batch documentation review per the requirement of Roche Timeline. 确保按照罗氏时限要求及时执行批文件审核。 Ensure products are not sold or supplied before a QP/AP has released, each production batch is produced and controlled in accordance with the requirements of the Marketing Authorization and other regulations relevant 确保每批商业产品的生产受控、满足上市许可及其它法规要求，在经QP/AP放行前不得被销售 Additional labeling IMP batch release. 对IMP重贴标批次实施放行 1.3 Execution of direct/ IMPmaterials management 对直接/IMP物料执行QA质量监管 Ensure on-time direct material batch disposition per Roche requirement 确保按照罗氏要求及时执行直接物料批处置 Implement oversight of material quality including Specifications, Artwork, SAP/MES master data, Change, DMS/CAPA, new material qualification, quality management etc. 对物料质量实施监管，包含质量标准、Artwork、SAP/MES系统主数据、变更、偏差/CAPA、新物料确认及质量管理等。 Support local supplier quality management including audit, Quality Agreement etc. 支持本地供应商的管理，包括审计、质量协议等。 C linical trial material shipping documents check and system release 负责临床试验物料的运输放行相关文件的核查和系统放行操作 Temperature excursion evaluation during transportation for local sourced IMP s. 负责本地罗氏临床试验药品 在运输 过程中的超温评估 Support the investigation of repackaging and IMP products complaints. 支持进口分包装产品和IMP相关投诉的调查 1.4 Coordination and handling for quality related issue / 质量相关事件的协调与处理 Implement the management of Event &CAPA：Be able to utilize RCA tools and can facilitate related departments to conduct discrepancy investigation, ensure the investigation completed within specified due date and supporting products release. 实施事件及纠正及预防措施管理： 能够运用根本原因分析工具，协调各部门进行偏差调查，确保偏差调查在规定时限内完成，支持产品放行。 Collaborate with SMEs and Lead investigators to develop investigation strategies 与调查领导者及相关SME协作，制定调查策略 Participate in Local Quality Council when needed 在需要时，参与本地质量委员会 Monitor investigation progress and ensure effective corrective and preventive

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