Currently works in a large domestic joint company and mainly responsible for EU GMP certification related work.
More than 10 years of working experiencerelated to pharmaceutical factory production and quality management, familiar with on-site quality control over preparations like oral solid preparations, sterile powder injection and external ointments etc. Involved in many plant construction projects; played a key role in thewhole processof plant design, layout, validation and certification for solid preparation and freeze-dried powder injection etc.
Familiar with relevant domestic and foreign GMP laws, regulations, guidelines;organizing quality system formulation; designed and developed pragmatic and applicable quality systems from GMP documentation, validation, changes, deviations and laboratory management etc. Expert in the current regulations audit and certification orientation; proficient in reception and companion of on-site audit.
Experienced in management and implementation of data integrity; lectured in courses like data integrity inspection, cleaning validation and environment monitoring etc. and received good comments from trainees and organizers.