钱玉春 Email and Phone Number

Report to VP of quality1. Established production QA team, from 1 person in 2018 to 13 in 20212. Established and managed the company's deviation, change and CAPA system, which has been running smoothly and effectively 3. Responsible for the management of on-site QA, laboratory QA and FUME QA, as well as production supervision, environmental monitoring, laboratory supervision, and equipment/system operation and maintenance supervision4. Assisted the company to complete the first product NDA, which had passed the PLI Onsite inspection, the Production department had no critical or major defects, and the MQA team had no defect5. Lead or participate in the company's self-inspection, support the supplier audit6. Established the company's product code and batch number rules, and supported the launch of SAP system7. Established the entrusted production management process of the company8. Responsible for product release, manage the implementation time limit at each process of product production, and ensure smooth release within the specified time limit9.Served as GMP trainer of the company

Report to Associate Quality Director1. To determine that systems, facilities, and written procedures are in compliance with GMP and Corporate policies. Participate in procedure initial, review and approve. 2. As one of the core member of PMX project，organize cross function team work to identify and solve the problems，make sure that all project process is in compliance with quality and business requirements，including process design，electronic tickets development，training，testing and go-live to commercial production.3. Perform quality assessment for deviation and impact analysis for change as QA assessor, take investigation for deviation and figure out CAPA and evaluate the effectiveness of implementation as quality SME.4. Worked as QA trainer to train the shop floor QAs and qualify them for their position duty. To be responsible for key operators qualification assessment and GMP training for production department employees..5. Perform in-process control during all the manufacturing and packaging process for Ceclor product. Assurance all process and operations in compliance with GMP regulations and site quality requirements.6. To be responsible for batch record review and release.To participate review or approve documents in Ceclor area.7. Review cleaning validation and process validation protocol and assist validation practice.8. Responsible for environment and utilities monitoring program to continuously evaluate, practice the environment monitoring for PD module, sample room, microbiological lab clean room, compress air and nitrogen system. Train and qualify the colleague to perform environment monitoring.9. To be responsible for sampling, reserve samples, and annual sample inspection management. 10、Deal with the material and vendor related issues. Participate in supplier quality management.

Report to Technical supervisor1. Lead cleaning team, make the cleaning plan, arrange shift, performance and training management of team members.2. Solving the problems of manufacturing process.3. Contact with the other departments (IT,QM,IS,SHE etc.) in order to support the production.4. Collect and analysis the data of production, Optimize the process and control the risk.5. Responsible for the process and cleaning validation.6. Routine GMP management(internal audit, GMP training for new operator, document management).7. Maintain the production environment: organize maintenance and repair of workshop facilities, coordinate the cleaning and disinfection of the production workshop and uniform, etc.8. Support general issues: manage the cleaning and disinfectant agent, appraise the performance of each process team monthly, coordinate external inspection, audit and the visit, etc.9. Routine management of production(On site inspection for mixing, filling, sterilization, packing. Review the BMR).

Report to QA Manager1. Make the sampling plan of raw materials and execute.2. Responsible for the evaluation and releasing of the materials, handling the rejected materials.3. Responsible for the work of NIR identification project.4. Vendor management (developing , maintaining, evaluation).5. Responsible for material reserve samples, and annual sample inspection. 6. Prepare for the external audit.

Report to QA Manager1. Assist quality manager in the establishment, operation, maintenance review of quality system.2. Responsible for the entire process site management and inspection of injection production.3. Responsible for the clearance inspection and release of intermediate products and review BMR.4. Organize, coordinate, participate in internal and external quality audit and execute the CAPA.5. Convene the meeting for review the quality of injection production.6. Conduct GMP training for new operators.

Report to Plant Manager1. Responsible for inspection on appearance and packing quality of purchased medicine according to the requirements of GSP and the company requirements , and release them.2. Involved in suppliers evaluation, destroy reject medicine.3. Handling complaints of customers and take CAPAs