岗位职责:
负责分析项目QA质量保证工作的执行
Be responsible for analytical project QA quality assurance work execution
审核分析项目相关文件：包括但不限于分析记录、COA、分析方法、质量标准、分析记录母本、稳定性方案和报告、分析方法的验证方案和报告等，确保相关活动符合合全/客户和法规的要求。
Review and approve project related documents, including but not limited to analysis record, COA, analytical method, quality specification, master analysis record, stability protocol and report, validation protocol and report of analytical method, ensure related activities meet the requirements of STA/customer and regulations.
按既定程序和标准批准测试报告和COA。
Approve test report and COA according to approved procedures and specifications.
协调偏差，实验室调查，变更，客户质量投诉调查，确保纠正和预防措施的有效执行和记录。
Coordinate deviation investigation, lab investigation， change control and customer complaint investigation, ensure the effective execution and record of corrective and preventive actions.
审核客户质量协议，保证合全提供的委托检测活动符合质量协议的要求。
Review the customer quality agreement, ensure the contracted testing activities of STA comply with the requirements of quality agreement.
参与客户审计及内部审计。
Participate in customer audit and internal audit.
确保QC实验室区域的日常现场检查按照要求进行。
Ensure the routine on-site inspections of QC lab is executed according to related requirements.
负责QA相关程序文件的起草，更新和审核，QC实验室相关流程的审核。
Be responsible for the QA procedures drafting, revision, and review. Review the procedures of QC lab.
完成主管安排的其他工作和任务。
Jobs and responsibilities assigned by the superior.
任职要求:
药学或化学相关专业，大学以上学历。
Major in Pharmacy or chemistry, bachelor degree or above.
了解制药生产、检测和质量管理，熟悉GMP相关法规。
Knowledge of pharmaceutical manufacturing, testing and quality management, familiar with GMP regulations.
熟练掌握英文
Proficient in English
计算机良好
Good computer skills
一年以上药厂质量管理相关经验
More than 1 year of experience in pharmaceutical quality management
较强地协调沟通能力
Strong coordination and communication skills
较强地问题调查能力和逻辑判断能力
Strong problem investigation ability and logical judgment ability
跟踪客户质量要求，保证实验进程不受影响，及时放行分析数据。
Follow up customer quality requirements to ensure that the experimental process is not affected and timely release analysis data.