LRQA has provided management system certification services and training services in China since 1995 and enjoyed as market leader in terms of reputation, service quality and technical integrity. We are now looking for suitable candidates to join our rapid growing team in China.
Key Responsibility: ? To undertake FDA regulation (CFR/ACT/GUIDE/STANDARD/AAMI/ASTM/ANSI) compliance review for assigned clients; ? To lead or participate in various type of assessments including preliminary assessments, initial assessments, follow-up visits, surveillances, solution recommendation, and customized project to contractual agreement requirements; ? To produce verbal and written assessment reports on time and to the agreed format ? To identify new and potential business opportunities, advise clients on LR and LRQA services and action any resulting leads; ? To lead or participate in special projects.
The successful candidate will have: ? Familiar with FDA regulation and ANSI and harmonized standards. ? Familiar with the ICH Q7 and software application validation and CGMP ? 2 years information on FDA product experience; ? Holding CCAA assessor registration is preferred; ? Local language, and good English speaking and writing skills; ? An enthusiastic and committed team player; ? Flexible on travel required. ? Have multiple scientific competence in Tobacco/pharmaceutical/medical device field. ? 2 years of testimony on relevant design experience.
In return, LRQA offers a highly stimulating work environment; excellent career development and training opportunities; opportunity to work with colleague across the world; and a competitive salary and benefits package as well as the opportunity to make a real difference.