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Quality Control Analyst (Chemistry)

  • Titre Quality Control Analyst (Chemistry)
  • Fonction Quality
  • Sous-fonction Quality Control
  • Lieu Hangzhou, Zhejiang, China
  • Date de mise en ligne
  • Référence 2306101197W
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1.  日常检验及复核工作:按计划按时准确完成原辅料、成品、稳定性样品、中控样品、投诉样的检测任务。按时完成原始记录复核工作,确保记录符合GMP、GLP要求。
Routine testing and reviewing work: Perform testing for raw material, final products, stability samples, bulk samples and complaint samples within required testing cycle time. Review raw data in time and make sure that the record meets GMP and GLP compliance requirements.
2.  协助高级分析师进行OOS/NC调查并找到根本原因。在高级分析师的协助下完成变更申请的相应行动计划。
Assist Senior Analyst to perform the OOS/NC investigation to find out the root cause. Complete the related action plan in the Change Request with guidance of Senior Analyst.
3.  针对当前实际操作流程撰写或修订合规的SOP/WI,并对员工进行培训指导。
Write or update compliant SOP/WI according to the actual operation process and guide employees.
4.  验证工作:按照草案或者程序要求完成实验室新方法的确认/验证工作。
Method qualification: Fulfill the new method qualification/validation according to approved protocols or procedure.
5.  技术支持:能提供相应化学分析相关的技术支持。
Technical support: Provide relevant technical support about chemical analysis.
6.  负责实验室仪器设备的管理工作,确保实验室仪器设备及时得到校验和维护,仪器设备处于正常工作状态。负责实验室新仪器设备的申购和验证工作,确保新仪器设备在投入使用前得到充分验证。                                                                                                                    
Responsible for the Lab instrument & equipment management, ensure all instrument & equipment calibration/maintenance timely and working well. Be responsible for new instrument & equipment purchase and validation, ensure new instrument & equipment is fully validated before use.
7.  严格遵循强生EHS政策,落实《安全生产法》及相关法规所要求的岗位安全责任,遵守本单位的安全生产规章制度和操作规程,正确佩戴和使用劳动防护用品,接受安全生产教育和培训,持续改进EHS工作流程,发现上报消除潜在隐患。
Follow up JNJ policy of EHS strictly, as well as Production Safety Law and relevant local regulations on the post safety responsibilities. Follow up procedures and work instruction, correctly use PPE and participate training. Contribute to continuous improvement the EHS working process of QC to eliminate potential risk.
8.  遵循ISO13485,GMP,21CFR Part 820,21CFR Part 211及公司政策,符合规定的要求,协助经理进行各种审计准备。
Comply with the requirements of ISO13485, GMP, 21CFR Part 820, 21CFR Part 211 and company regulation, assist manager in audit preparation.
9.  其他:执行其它工作任务,例如团队的紧急任务, EHS相关工作。


1. 药学,药物分析,分析化学或相关专业,大专及以上学历。
Junior college degree or above in Pharmaceutical science, pharmaceutical analysis, analytical chemistry, and related specialties
2. 大专学历至少2年医药或医疗器械跨国公司化学实验室工作经验;或者知名大学本科或研究生应届毕业生。
At least two years related experience in the chemical lab of pharmaceutical or medical devices international company with Junior college degree; or a well-known university graduate with Bachelor’s degree, or a graduate with Master’s degree.
3. 具备GMP以及GLP的基本知识。
Common knowledge of GMP and GLP.

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