成都MQA

职位名称：成都 Manufacturing QA

岗位职责：

Job Responsibility

1、 负责药品生产的全过程的质量监督，保证所制定的各项操作规程符合GMP要求并贯彻执行，以保证药品产品质量。

Responsible for monitoring quality of the whole manufacturing process to ensure all operations be executed as per SOP and GMP requirement for product quality.

2、 负责原液或制剂车间的生产现场检查，电子数据审核，相关生产批记录的审核。

Responsible for DS or DP online quality monitoring, electronic data review and BPR review.

3、 负责及时发现生产线在线问题并及时上报，并对生产或产品做出紧急处理建议，确保潜在问题产品可控，不会流入下道工序。

Responsible for timely identify the online problem, give immediately disposition suggestion, ensure the issue product under control in a timely manner when it presents, to ensure it would not be in the next process.

4、 负责生产区域功能间的清理和清场的检查和放行。负责生产车间设备的放行工作。

Responsible for inspection and release of clearance and changeover in function rooms in manufacturing area; responsible for equipment release in manufacturing area.

5、 参与工厂偏差、变更及投诉等调查、影响评估，参与CAPA制定及有效性确认并审核调查报告。

Participate in site deviation, change and complaint investigation and perform impact assessment, participate in CAPA initiation and effectiveness check and review investigation report.

6、 负责审核质量相关文件，例如：主生产记录、批生产记录、质量风险评估等。

Responsible for reviewing quality related documents, eg: MBR, BPR,QRM, etc.;

7、 审核细胞库、原液（含外来原液）批放行相关的文件，确保所放行的细胞库和原液（含外来原液）满足要求。

Review the batch release package for cell back and drug substance (including external drug substance), ensure the released cell bank and drug substance (including external drug substance) meet the requirement.

8、 负责批生产记录的受控发放和回收。

Responsible for controlled distribution and recovery of BPRs.

9、 参与技术转移，审核新产品引入相关文件。

Involved in the technical transfer process, review new product introduction related documents.

10、 参与工艺验证、持续工艺确认及工艺优化相关的活动，审核相关的文件。

Involved in process validation, continuous process verification and process optimization related activities, review related documents.

11、 作为放行负责人，负责建立产品放行体系并维护良好运行，负责DS/DP产品的批审核及支持放行，确保每批已放行产品的生产、检验均符合相关法规、药品注册要求和质量标准；产品放行前，出具产品放行审核记录，并纳入批记录。

Being responsible for establishing product release system and maintaining good operation, batch review and supporting release of DS/DP products, and ensuring that each batch of released products is manufactured and tested in accordance with relevant regulations, drug registration requirements and specifications. Issue product release record and attach in batch record before product release.

12、 建立/维护CCS文件。

Establish and maintain CCS documents.

13、 参与年度产品质量回顾相关工作。

Participate in annual product quality review.

14、 作为审计支持人员参与质量审计工作的准备，如资料的收集及审核等。

Responsible to support quality audit readiness, e.g. supporting document collection and review.

15、 遵守公司的规章制度，遵守保密制度，坚持保密原则。

Obey the regulations of company, obey the confidential regulation and insist the confidential principle.

16、 完成上级交办的其他工作。

Finish the other jobs assigned by the supervisor.

教育程度/经验：

Education/Experiences

1. 本科及以上学历，生物制药相关专业；

Bachelor degree above, biopharmaceutical major;

2. 5年以上药品或生物制药QA的工作经验；

At least 5 years of pharmaceutical QA working experience.

技能要求：

Skills

1. 良好的英语读写能力。

Well verse in reading and written English.

2. 熟练的使用计算机办公软件。

Skillful in using computer software.

3. 有良好的沟通技巧，工作认真、细致，具有良好的团队合作精神。

Good communication skill, attentive, careful and meticulous, with strong team-work ability.

4. 熟悉欧盟、中国和美国GMP法规相关要求。

Familiar with GMP regulations and requirements of EU, CFDA, and FDA.