职位信息

Ensures that the commissioning and qualification of the commercial manufacturing facility comply with appropriate regulatory requirement and construction code; 

Lead the C&Q project implementation;

Coordinate all parties in C&Q execution; 

Support validation related audit/visit by clients and regulatory authorities; 

教育程度/经验Education background/ Experience 

Bachelor degree or Above

特别知识Special knowledge

Familiar with regulatory requirements and industry standards, such as 21 CFR Part 210/211/11, Annex 11 of EU GMP, GAMP 5, ICH Q9/Q10; ISPE baseline guides, and PDA TRs in cleaning and process. 

技能Skills 

Be experienced in validation and qualification activities and system lifecycle form requirements analysis or product development to commercialization manufacturing, covering various equipment/facilities/utilities/computer systems or cleaning/analytical methods/processes. 

其他要求（比如工作时间等）Other requirements

At least 8 years of working experience in validation