Associate Manager/Senior Specialist-ASAT

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 1. Primary Purpose of Job (Job Summary)主要工作目标（岗位简介） Ensure quality & regulatory compliance of products manufactured in SRPL by effective management of Quality Control system functions in meeting business goal of company. Provide best practice such as GMP and GLP in Labs to compliance the current global standards. 通过对质量控制体系的有效管理，确保上海罗氏生产的药品符合有关质量和法规要求，满足公司业务目标。向实验室提供实践GMP和GLP规范要求，使实验室符合最新的国际化规范。 General:主要要求 · Managing validation, qualification, and transfer and troubleshooting of analytical methodologies according to current Roche

and regulations. 根据罗氏的现行要求和法规，管理分析方法的验证、确认、转移以及故障排除。

• Ensure pharmacopeia compliance in site and support ChP compliance across network 确保工厂的药典符合性并支持集团内中国药典的符合性 · Manage the sample and reference standard to meet the testing needs in China area 管理样品和标准品已满足中国区的测试需求 · Manage the stability program to support China business 管理稳定性计划已支持中国业务 · Supporting and executing QC activities related to process and cleaning validation, special analytics, investigations and non-routine testing. 支持和执行QC相关的工艺验证、清洁验证、特殊分析、调查和非日常测试。

• Managing analytical trending process in labs according to current Roche requirements and regulations 根据当前的罗氏和法规要求，管理实验室的趋势分析流程 · Developing and implementing the new technology roadmap, in collaboration with other QC labs and Global functions or PTD. 同其它QC和总部职能部门或PTD合作，发展和执行新的技术路线图。

2. 02

   Principle Roles & Responsibilities / Accountabilities 主要职责/责任 Implement GMP compliance with global GMP standards and China GMP requirement 根据总部和中国GMP要求，执行GMP符合性工作 · Sample receipt, storage, distribution and disposal procedure management. 样品的接收、存储、分发及处理流程的管理。

• Reference and retention sample management. 参考留样及常规留样的管理。

• Excute analytical transfers and local analytical method verifications. 执行分析方法转移和本地分析方法确认。

• Ensure process and cleaning validation analysis execution. 确保工艺验证和清洁验证的执行。

• Maintenance of QC specifications and analytical methods. 维护QC的质量标准和分析方法。

• Packaging material standard sample management. 包材的标准样管理。

• Maintenance of Master Method Validation Plan and the timely execution of method validation protocols and reports 维护验证主计划，及时执行方法验证计划和报告。

• Third party QC labs management 第三方实验室管理。

• Provide technical guidance on test methods and relevant procedures. 对测试方法和检测过程提供技术支持。

• Ensure support on manufacturing operations through troubleshooting and other product lifecycle testing. 确保支持生产过程中的故障排除和其他的产品生命周期测试。

• Manage the trending process in labs according to Roche PQS requirements and regulations 根据罗氏PQS和法规要求，管理实验室的趋势分析流程 · Ensure that CMC regulatory submissions are aligned with QC specifications and analytical methods. 确保QC的质量标准和分析方法和CMC注册文件一致。

• Ensure that QC specifications and analytical methods comply with applicable pharmacopeias requirements 确保QC的质量标准和分析方法符合相关药典要求 · Support Chinese Pharmacopeia commenting and implementation across the network 支持中国药典在集团内的意见反馈与执行 · Stability program - chamber management, coordination with global and laboratories for timely execution of stability protocols and stability report, stability trending 稳定性计划-箱子管理、协调总部和实验室以保证稳定性方案、报告以及稳定性趋势分析的及时执行 · QC metrics generation and report, managing performance of quality system processes (TCM, Discrepancies, CAPA, etc) for QC QC量度的生成及报告，管理QC相关的质量体系（变更、偏差、CAPA等）的指标 · Reference standards management 标准品管理 · Provide QC technical support and oversight to CMO activities 对CMO活动提供QC技术支持和监督 · Support regulatory inspections and partner audits 支持官方审计和合作伙伴审计 Ø Qualification and Experience 能力与经验 Education/Qualifications教育程度/所获资格证书 Ø Bachelor’s Degree((biology, microbiology, biochemistry discipline is preferred) 学士学位 ( 生物，微生物，生物化学优先) Ø Graduate or higher-level Degree is preferred 更高学历优先 Ø At least 4 years' experience in analysis of Biological drug products. 至少4年生物制剂分析经验 Job Required Competencies岗位所需胜任力 Ø Expert knowledge of compendial test methods (e.g. ChP, USP, EP, JP) for Pharmaceutical Industry 制药行业药典方法（例如ChP，USP，EP，JP）的专业知识 Ø Relevant CMC regulation and cGMP knowledge of the pharmaceutical industry 制药行业相关的注册法规和cGMP知识 Ø Relevant knowledge of Quality System principles, practices and standards for the pharmaceutical industry 制药行业质量体系原则，实践和标准的相关知识 Ø Demonstrate excellent verbal and written communication skills in English 表现出良好的英语口语和书面沟通能力 Who we are A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact. Let’s build a healthier future, together. Roche is an Equal Opportunity Employer.