南京招聘

职位描述：
Compliance and Engineer of TQ Senior Consultant
API/Excipient manufacturing (including high potent compounds);
Or Finished Product manufacturing;
Or Sterile productions (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 person will be responsible to work in different projects related to Technical Qualification and Engineering. The person will work alone or more frequently coordinating multidisciplinary teams. Responsibilities include, but are not limited to, the following:
Development of qualification plans, user/technical requirements specifications, design qualification reports, test plans, requirements-testing traceability matrixes, qualification summary reports
Development of installation, 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 plans for new sites implementation including detailed Gantt charts with predecessors and resources workload evaluation (advanced knowledge of Microsoft Project requested)
Knowledge of the main test instruments suites (e.g.: GE Kaye Validator, Thermal validation studies data loggers, HVAC test instruments, calibration instruments)
Coordination of junior resources for qualification testing execution and use of test instruments
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 plans and related instructions
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 loggers, HVAC test instruments, calibration instruments）
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 years’ 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*** 举报 分享

PQE公司成立于1998年，作为欧洲领头的整体质量打包解决方案服务公司，以200多名专家咨询师的优势，服务领域包括质量系统、合规注册和验证确认等领域。更致力于为客户提供数据完整性保障(Data Integrity Assuance）的整体解决方案。我们已在全球45个国家，参与或主持了8，000多个项目。我们的客户包括全球知名跨国企业和地方领头企业。我们是山德士、特瓦等公司的全球服务伙伴，同时也与赛诺菲、辉瑞、罗氏、诺华等知名制药企业保持长期稳定合作关系。

PQE目前已进入中国市场，服务中国企业。我们期望能成为一个成本最优、品质最高的服务咨询公司。将秉承We Act Locally,Think Globally的商业理念。