Compliance and Engineer of TQ Senior Coultant

?API/Excipient manufacturing (including high potent compounds);

? Or Finished Product manufacturing;

? Or Sterile productio (both APIs and FPs);

? Or Pharma distribution (APIs and FPs)

原料药／辅药生产（包括高效化合物）

成品制造

无菌生产（APIs及FPs）

制药(APIs及FPs)

In this full-time role, the peon will be respoible to work in different projects related to Technical Qualification and Engineering. The peon will work alone or more frequently coordinating multidisciplinary teams. Respoibilities include, but are not limited to, the following:

? Development of qualification pla, usetechnical requirements specificatio, design qualification reports, test pla, requirements-testing traceability matrixes, qualification summary reports

? Development of itallation, operational and performance qualification protocols for equipment and utilities (e.g.: HVAC, Water Systems, Process Gases), according to the current internationally recognized guidelines (e.g.: ISPE, GAMP)

? Development of thermal validation study protocols

? Development of project validation master pla for new sites implementation including detailed Gantt charts with predecesso and resources workload evaluation (advanced knowledge of Microsoft Project requested)

? Knowledge of the main test itruments suites (e.g.: GE Kaye Validator, Thermal validation studies data logge, HVAC test itruments, calibration itruments)

? Coordination of junior resources for qualification testing execution and use of test itruments

? Development of risk based assessment at process, component and functional level according to the internationally recognized methodologies (e.g.: FMEA, HACCP)

? Development of calibration and maintenance pla and related itructio

? Development of standard operating procedures

? Advanced knowledge of EU and US GMP

申请该全职岗位的人需要参与技术确认和工程相关项目,既能独立工作也能与多领域专家组成的团队一同工作.职责包括但不限于以下:

编写确认文件和计划,用户需求/技术要求,设计确认报告,测试计划,可追溯性的需求测试,确认工作的总结报告

依据最新的国际法规及指南，进行设备及公用设施的安装确认,运行确认,和性能确认的测试方案的起草(HVAC,水系统,工艺气体)

开发及执行热力学分布研究

开发项目验证主计划，使用先进的管理工具（包括Microsoft Project），对人员工作量进行安排

有使用主要测试仪器的相关知识（GE Kaye Validator, Thermal validation studies data logge, HVAC test itruments, calibration itruments）

管理初级验证人员测试执行和确认仪器的使用

以风险为基础对生产工艺进行评估并熟悉使用相关风险工具（FMEA, HACCP）

开发制作校验和维护计划及相关流程

SOP的编写

熟悉EU及US GMP要求

Requirements:

？Fluent English (Mandatory)

？Technical Degree (Engineering, Chemistry, Informatics, Physics, Mathematics)

？Minimum of 3 yea’ experience in the drug manufacturing area

？Aptitude for travel (Mandatory)

？Integrity, strong analytical skills and attention to detail

要求：

英语流利（必须）

工科背景（工程，化学，信息，物理，数学）

? Fluent in other languages

? MD or PhD in technical fields

?其他语种流利

?工科领域硕士或博士

LANGUAGES:

？English (fluent): mandatory

语言：

英语流利（必须）

工作地点在武汉或上海

该岗位适合***