制定明确清晰的验证确认概念，指导客户在正确的时间正确地执行测试，保证项目的顺利实施。

职责
1. 执行GMP咨询验证及确认项目，如：厂房、设施、设备、公用系统如空调系统、水系统、蒸汽系统；审核相关文件 ；
2. 审核和执行制药行业等的工艺验证、清洁验证，和/或 IT验证（如能执行IT更佳）
3. 主导编写GMP相关的技术文件，执行风险评估等；
4. 其他相关服务项目的协助与支持：如制剂及原料药厂的差距分析，图纸审核等；
5. 项目谈判过程的技术支持。

要求：药学、制药工程、化学、生物科学等相关专业；5年以上制药企业质量、生产或工程部门的相关工作经验；对制药行业的设施设备及公用系统，在工程和验证确认方面有一定的工作经验；依照FDA，EU，ISPE，ICH等法规和指南，熟悉验证要求；能够适应出差。

Definite qualification and validation concepts, guide customers to execute test in right time for keeping the smooth process of projects.

Responsibilities:Execute GMP validation and qualification consulting projects, including plant validation, facility validation, equipment validation and synergic system (air conditioning systems, water systems); review the related documents;Review and execute process validation, cleaning validation and/or computerized system validation in pharmaceutical industry (can execute computerized system is preferred);Participate in drafting GMP documents and executing risk assessment;Support and assist other related services e.g. gap analysis in preparations and API compliance analysis and design review;To provide technical support during business negotiation.

Qualification:

Graduated in related fields such as pharmacy, pharmaceutical engineering, chemistry and biotechnology;At least 5 years working experience in quality, production and engineering department;With engineering and validation experience on facility, synergic system production is need;Be familiar with the requirements of validation according to the regulations and guides of FDA, EU, ISPE, ICH etc.;Available for short term business trip.