Role & Responsibility Implement GMP compliance with global GMP standards and China GMP requirement By assisting manager to conduct GMP self- inspection, and following-up the implementation action to maintain the global level of GMP compliance. By maintaining the quality system and documentation system to ensure quality system operation in QC meet the regulatory requirement. Effectuate management of sample distribution and analytical process inspection to ensure timely releases of analytical report to support business need. By managing working schedule of relative section, to optimize utilization of human resources. By monitoring the analysis process to supervise the analytical report issued in reasonable lead time. By monitoring the timely calibration and maintenance of instrument within working section, to ensure they are functional well. By monitoring the timely entering and complementing of lab materials, including but not limit to reagent, solution, column/capillary and reference standard in working section, to ensure sufficient supply. Assist lab manager to complete the assigned routine testing, issue the reliable analytical report in reasonable lead time. By mastering analytical methods within working section, complying with professional morality and etiquette to ensure reliability and integrity of the analytical data and keeping the excellent capacity of working suitability. By rationalizing time allocation, optimizing combination the samples in hand to keep the reasonable lead time. By forming a good working habit to standardize experimental operations. By checking analysis result seriously and carefully to minimize mistakes and ensure accuracy and reliability of testing figures. Assist lab manager to coach subordinates to fulfill analysis tasks. By providing technical support to analysts and sharing knowledge and experience within working section if necessary. Report the abnormal status, unexpected results to supervisor with initiative and in time. By reporting abnormal status and unexpected results during analysis processing at first time by detailed data and information to alert supervisor to investigate and solve the problem in correct way and in time. By involving the investigation process to provide actual data and information to help avoid the same issue occurring again. Implement the analysis method validation. By initiating the specified analysis method validation via planning, executing and reporting process. By organizing the resources to complete yearly method validation plan. Implement the maintenance and calibration of the assigned instruments By accomplishing the calibration and maintenance of the assigned instruments, to ensure they are functional well to meet the analytical needs any time. By keeping the relevant document to trace the calibration & maintenance history and any change of the instruments. By keeping contact with instrument company to obtain the sufficient application technical support and repair service in time. Assist manager to support on HA lab including in-country testing and collaboration By trouble-shooting for in-country testing New biologics product launch preparation, e.g., reagent and consumable preparation. Technical collaboration with HA lab, e.g., method development, method validation Abide by lab safety regulations to prevent occurrence of accident. By obeying the safety instruction of the storage, usage and disposal of reagent, *********, medicines, lab waste. By following the usage instruction of facilities of water, electricity and steam etc. in lab. By clearing the working space in time to follow company safety rule, and patrol working section at the end of working day to secure the safety of lab. Have the ability to find and solve the problems occurred in routine work. By finding and solving the problems in correct way and in time during the experiment process, to ensure the normal operation of routine work. Qualification and Experience Education/Qualifications Bachelor of Science Degree or above Pharmacy, Chemistry, Biochemistry and equivalent Master at analytical science of Biological Product; At least 4 years’ experience in analytical testing and method validation of biologics Job Required Competencies Project management skills Language skills – English & **************************