QC Analyst

Job description

Job Description

Guarantee the quality of pharmaceutical products by means of comprehensive analysis and comparing resulting data with Novartis standards, as well as statutory requirements of PR CHINA.
1. Performing analysis test of FP, ST and FUST according to Novartis Control procedure and local registration analytical methods strictly, supply accurate results in time. 严格按照诺华控制程序和本地注册的分析方法来进行成品和稳定性分析，并按时提供准确的结果。 2. Carry out analysis for process validation of product, special samples and complaint samples. 进行工艺验证产品，特殊样品和投诉样品的分析。 3. Ensure all trainings are completed before execute testing. Complete training in relevant system (including LMS, Esop, ilearn, etc.) on time. 在执行测试前，完成所有相关的培训；及时完成相关系统的培训，包括LMS系统、ESOP、ilearn等。 4. Perform the relevant testing. The testing result is assessment against specification. No products are released from QC, until their quality has been judged to the satisfactory. 执行相关的测试，将测试结果与标准进行评估比对，保证在测试合格前，产品不会被放行。 5. Perform the relevant testing activity (product testing, stability sample testing, process validation sample testing, special and compliant sample testing, etc.), and submit the testing result in time. 执行相关的测试活动（产品测试，稳定性样品测试，工艺验证样品测试，特殊样品和投诉样品等）， 及时提交实验结果。 6. Perform the relevant testing in appropriate analytical instrument; check the status of analytical instrument before testing; ensure the analytical instrument is qualified. 在适当的分析设备上执行相应的测试，在测试前要检查设备的状态；确保分析设备是经过确认的。 7. Use the reference standards, reagent and solution in lab according to current SOP. 依据现有的SOP使用实验室对照品、试剂和溶液。 8. Use the glassware in lab according to current SOP and check the status of glassware before using; ensure the glassware is calibration. 依据现有的SOP来使用实验室的玻璃仪器，在使用前检查玻璃仪器的状态，确保实验室的玻璃仪器都是经过校验的。 9. Record the relevant logbook on time and ensure that no non-compliance case occurred. 及时记录相关的logbook，确保无不合规的事件发生。 10. Participate the lab investigation and deviation investigation, ensure the OOS/OOE and Deviation investigation report is scientifically, logically and reasonable. 参与实验室调查和偏差调查，确保OOS/OOE和偏差的调查报告是科学的、有逻辑的和合理的。 11. Ensure all activities in line with GMP and DI. 确保所有的行动满足GMP和数据完整性的要求。 12. Sustain the status of 6S in QC lab; ensure the 6S meet the requirement. 维持QC实验室的6S状态，确保6S满足要求。 13. Support the lean lab project and Kaizen project and ensure the implementation in QC lab. 支持精益实验室及改善项目，确保在QC实验室的实施。 14. Support the QC KPI Complete, e.g. NOSSCE KPIs etc. 支持QC绩效指标的完成，例如NOSSCE KPI。 15. Follow health & safety procedures. I.e. near miss accidents, workstation assessment etc. Provide support to our HS&E department. 遵守健康和安全规程，如：未遂事件，岗位评估等；为健康安全部门提供支持。 16. Conduct those urgent tests and work to be required by QC Coordinator. 服从领导分配的其他工作任务。

Desired profile

Minimum requirements

Bachelor Degree in Pharmaceutical, Chemical or Analytical 药学，化学或分析专业本科学历 Chinese and English 中文和英文 2 years’ experience in QC lab is preferred. 在QC 实验室有两年的工作经验优先