药明生物｜文件培训实习生

Be responsible for the Document training management of manufacturing to ensure the smooth running of the project manufacturing, including the management of identifying training needs, tracking the qualification of operators, qualification monitoring and maintenance. Key roles and responsibilities 1. As MFG contacting person to guide operators to fill in the corresponding training forms and provide guide as necessary. 2. Responsible for assisting department management team to follow up training completion status. 3. Responsible for collecting and sorting department training records and deliver to QA. 4. Assist on the forms filling when employee rotation or resigns, such as JD, CV, job code, trainer form and etc. 5. Support the establishing of personal training binder, including but not limited to job description (JD), curriculum vita (CV), signature and initials registration. 6. Support the re-training or continuous training for operators. 7. Support the trainer applying for the SME of related functions. 8. Responsible for distribution, recovery and destruction of controlled documents 9. Responsible for distribution and destruction of MBR 10. Responsible for archiving GMP documents

Requirements 1. College degree or above, major in pharmaceutical related subject 2. More than one-year internship is preferred, working at least four days per week 3. Good English in read and write, good English speaking is a plus 4. Knowledge of FDA, EU, WHO, NMPA GMP related requirements 5. Be familiar with Microsoft office software for document handling such as Word, Excel, Power point, Visio etc. 6. Have the ability to use tools such as PSP to analyze and solve problems 7. Pro-active, high sense of responsibility, self-discipline 8. Production-oriented comprehensive working system, can respond at any time 9. Excellent communication, problem-solving, and organization skills, attentive, careful and meticulous, with strong team-work ability