体系QA专员-北京

工作内容：
1.客户审计支持。
Client Audit Support.
1.1 客户审计的项目信息收集及文件收集。
Responsible for colleting the project information or requested documentation prior to client audit.
1.2 客户审计过程支持及协调各部门SME回答审计员问题。
Responsible for supporting the client audit and coordinate the SME of each department to answer the auditor’s question.
1.3接收客户审计报告，将审计缺陷项按部门分类，组织各相关部门准备审计回复。
Receive client audit report, classify the observations and organize related departments to prepare the response.
1.4 汇总并审核各部门起草的回复，将完成的回复发送给客户。
Collect and review the response of each department, then send the completed response to client.
1.5 负责质量管理体系中的纠正措施和预防措施的审核、存档和跟踪，并按协商的要求将CAPA完成情况及时反馈给客户。
Responsible for reviewing, archiving, and tracking CAPAs in the quality management system and give the feedback to client as per the harmonized agreement of both parties.
2.质量协议维护和管理。
Quality Agreement Maintenance and Management.
2.1 负责质量协议模板的维护和更新。
Responsible for maintenance and update of the quality agreement template.
2.2 对质量协议进行审核，并组织各相关部门参与审核，并将审核意见反馈给客户。
Review the quality agreement and organize related departments to participate in the review, then give the feedback of review comments to client.
2.3 按照与双方协商的要求或SOP的规定，定期对质量协议进行更新。
Update quality agreement as per the harmonized agreement with client or Pharmaron SOP.
2.4 以签署质量协议的项目启动时，负责对项目相关人员进行培训。
Responsible for training relevant personnel when starting a project which has been signed the quality agreement.
2.5 对已签署的质量协议分类存档。
Archive the signed quality agreement.
3.客户调查问卷的填写和存档。
Filling and Archiving the Questionnaire from client.
3.1 填写客户发送的调查问卷，完成后发送给客户。
Fill in the questionnaire sent by client and send the completed questionnaire to client.
3.2 存档已完成的调查问卷及其附件。
Archive the completed questionnaires and related attachments.
4. 负责内审组织和执行。
Responsible for organizing internal audit.
5. 负责CAPA追踪管理。
responsible for CAPA follow-up.
6.负责法规查新，并进行差距分析。
Responsible for the GMP regulation or guidance surveillance, and perform the gap analysis as appropriate.
7.其他Other
7.1. 参与完成本部门领导临时安排的工作。
Complete other tasks arrangements by department head.
教育背景及任职资格：
1.教育背景：化学、应用化学、药学或其他相关专业本科及以上学历。
Education Background: bachelor degree or above in Chemistry, Applied Chemistry, Pharmacy or other related majors.
2.经验：应当至少具有药学或相关专业本科学历（或中级专业技术职称或执业药师资格），具有至少3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。
Experience: At least a bachelor degree in Pharmacy or related major (or a secondary professional technical title or Licensed Pharmacist qualification), with at least 3 years of practical experience in pharmaceutical production and quality management, and have trained in professional knowledge related to the products produced.
3.技能技巧：具有一定的专业英语读写能力。 要求大学英语六级水平。
Skills: have a certain ability to read and write in professional English. CET 6 English certificate is required.