Clinical Operations and Regulatory Affairs, Suzhou | 30 Sep 2021
Participate in or responsible for qualification of process equipment.
Participate in or responsible for production related process validation, cleaning validation, etc.
Responsible for the creation, optimization and update of production SOP, batch records and other documents.
Responsible for review relevant records timely and follow-up execution of on-site ESH and 5S.
Support team to organize and arrange production operations according to production plan, assist in the implementation of GMP on production site, complete production operations according to SOP and batch records, and ensure meet the objectives of quality, output, yield and efficiency.
Participate in dealing with deviation, change and risk management related to production, solve problems encountered in the production process, and constantly optimize the production process.
Responsible for the production of clinical products.
Summarize and report production related data, and complete other work arranged by production manager.
Bachelor’s degree or above, major in related pharmaceutical or electrical and automation; at least 3 years’ experience of drug production; related work experience in oral solid production or similar position is preferred.
Good communication, coordination and problem solving skills, proficient in English.