北京招聘

1.负责起草和监控工艺过程关键控制点。
Responsible for drafting and monitoring production process critical control point.
2.确保制剂产品生产制造和检测过程符合法规和注册要求；
Ensure GMP compliance and registration requirement in DP manufacturing process/analysis process
3.生产现场巡查，包括灌装，包装和成品检验和放行；
Routine in process inspection, including filling, packaging and final product checking;
4.负责生产过程的偏差、异常情况原因调查及风险评估，及时报告并提出建议，负责确认处理结果。
Responsible for the cause investigation and risk assessment of deviation and abnormal situation in the production process, timely report and make Suggestions, and confirm the result.
5.严格按照清场管理制度监督各工序清场情况，监督状态标志的使用，监督相关GMP文件在生产全过程的执行情况。
Supervise the of each process in strict accordance with the clearance management system, supervise the use of status signs, and supervise the implementation of relevant GMP documents in the whole production process.
6.负责批生产记录审核。
Responsible for batch production record audit.
7.监督不合格品的处理程序。
Supervise the disposal procedure of rejected products.
8.领导安排的其他工作。
Working task which is arranged by direct supervisor.
职位要求：
职位需求 Job Requirement
1.药学、化学、微生物学或相关学科学士或以上学位。
Bachelor or above degree in Pharmaceutical, Chemical, Microbiological or related field.
2.至少一年QA和无菌生产工作经历和/或医药行业工厂工作经验At least 1 year in Quality Assurance and/or in a manufacturing environment within the pharmaceutical industry.
3.熟悉CFDA cGMP、EU cGMP、PIC/S cGMP及FDA cGMP的要求。
Familiar with the regulatory requirement of CFDA cGMP、EU cGMP、PIC/S cGMP and FDA cGMP.
5. 熟悉质量系统提升及质量要素的管理。
Familiar the management of quality system improvement and quality elements.
6.具有较强的处理、分析和解决问题的能力。Strongly address, investigate and solve ability.

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