制剂现场QA-宁波

工作内容：
1.负责监督制剂生产车间的现场操作按照GMP、SOP及批生产记录进行操作，确保生产操作的一致性及合规性；
Responsible for supervising the on-site management of the DP Plant, to ensure the consistency and compliance of production operation in accordance with GMP, SOP and BPR requirement;
2.负责监督制剂生产车间的SOP、记录执行情况，确保SOP及记录为现行版本，并确保记录的填写符合数据完整性相关要求；
Responsible for the management of document and record in DP Plant, to make sure SOP and record was the current version, and to make sure that record in accordance with the requirements of data integrity;
3.负责监督制剂生产车间的状态标识执行情况，确保车间各项状态标识管理符合SOP要求；
Responsible for the management of identification label in DP Plant, to make sure the implementation of status identification in accordance with the SOP requirement;
4.负责监督制剂生产车间的清洁、清场执行情况，确保清洁、清场操作符合SOP要求；
Responsible for the management of Clearance/Cleaning in DP Plant, to make sure the implementation of Clearance/Cleaning operation in accordance with the SOP requirement;
5.负责制剂生产车间空气净化系统、纯化水系统、压缩空气系统等公用设施的现场管理，确保公用设施的运行、维护保养、记录等符合要求；
Responsible for the management of facility（including HVAC system、PW system、Compress air system） in DP Plant, to make sure the operation & maintenance of facility in accordance with the SOP requirement;
6.负责根据文件要求起草及审核公用系统趋势分析；
Responsible for the quality review report of facility（including HVAC system、Compress air system）;
7.负责审核制剂生产车间计量器具分类清单、校准计划及校准记录,确保制剂生产车间的计量器具管理符合SOP要求，并根据校准报告发放校准标签；
Responsible for the management of measuring instrument in DP Plant, to make sure the implementation of measuring instrument（including Classification List 、Calibration Plan、Calibration Record） in accordance with the SOP requirement; Deliver the Calibration Label to DP Plant after the review of Calibration Certificate report;
8.完成本部门领导临时安排的工作。
Complete other tasks arrangements by department head.
教育背景 Education Background
1.化学、应用化学、药学或相关专业本科以上学历
Bachelor degree or college degree above in chemistry, applied chemistry, pharmacy or other related on-sites.
2.应当至少具有药学或相关专业本科或专科学历（或中级专业技术职称或执业药师资格）。本科学历，具有至少1年从事药品生产和质量管理的实践经验，接受过与所生产产品相关的专业知识培训。大专学历（或中级专业技术职称或执业药师资格），具有至少2年从事药品生产和质量管理的实践经验，接受过与所生产产品相关的专业知识培训。
A bachelor degree or college degree above in pharmacy other related on-site (or qualified mid-level with the title in professional or licensed pharmacist), bachelor
degree, more than 1 years of experience in drug production and quality management, trained in professional knowledge related to the products produce.
college degree (or qualified mid-level with the title in professional or licensed pharmacist), more than 2 years of experience in drug production and quality management, trained in professional knowledge related to the products produce.