Associate Manager/Senior Specialist-ASAT

在罗氏，我们鼓励每位同事展现真实的自己；我们欣赏独特且出众的品质。罗氏的文化鼓励积极的表达、开放的对话和真诚的连结，在这里，你将因为做自己而被重视、接纳和尊重，并得到个人的提升和职业的发展。所有的这一切，都是为了更好地预防、阻止和治愈疾病，并确保医疗资源的可及性和可持续性。欢迎加入罗氏，一个重视每种声音的地方。

职位

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 requirements 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. 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

我们是谁

打造更健康的未来是促使我们创新的动力。全球超过100,000名员工共同致力于推进科学，确保今天和明天的人们，都能获得高质量的医疗资源。我们的努力帮助了2600多万人使用我们的药物进行治疗，我们的诊断产品运行超过300亿次检测。罗氏通过赋能探索新的可能、激发创造力并保持高标准以提供突破传统的医疗解决方案，对全球的医疗环境带去推动和影响。

让我们一起，构建更健康的未来。

罗氏提供平等的职业发展机会。