生物/制药 工作职责
1.Review and approval of COA for Raw materials, in process, finished product and stability samples. 审核和批准原料、中间品、成品和稳定性样品的COA
2. Review of IQ/OQ/PQ protocols for analytical instruments and execution. 审核分析仪器的IQ/OQ/PQ方案及执行。
3. Review of Qualification, calibration, Preventive maintenance records of instruments / Equipments.审核仪器/设备的确认、校准和预防性维护记录。
4. Review of Method transfer / Method verification / Stability protocols. 审核方法转移/方法验证/稳定性方案。
5. Preparation, Review and Approval of specifications in LIMS. 在LIMS中质量标准的准备，审核和批准。
6. Verification of Pharmacopoeial Compliance of the Specifications and Method of Analysis. 质量标准和分析方法的药典合规性的验证。
7. Inspection of Quality control laboratory. Auditing of external contract testing laboratories. 质量控制实验室的自检，外部合同测试实验室的审计。
8. Review of audit trials and esign in Chromatographic Software Empower and standalone instruments (Softwares). 审核色谱软件Empower和独立仪器（软件）的审计追踪和电子签名
9. Ensuring the software Data backup and verification of backup data on periodic basis.确保软件数据备份和定期验证备份数据。
10. Ensuring the status Material/Product satus in ERP. 确保物料/产品在ERP中的状态。
11. Review of Monthly trend report related to water etc. 水月度趋势报告的审核。
任职资格
1.至少3年以上的HPLC操作实验经验，1年以上的GC操作实验经验。
2.熟悉Empower等HPLC系统的操作，审计追踪和备份，色谱图的处理和积分。
3.熟悉分析方法转移操作
4.熟悉原辅料、成品、中间产品的检验记录及COA的审核，善于发现异常
1. At least 3 years of experience in HPLC operation experiments and 1 year of experience in GC operation experiments.
2. Familiar with the operation of HPLC systems such as Empower, audit tracking and backup, as well as the processing and integration of chromatograms.
3. Familiar with analysis transfer methods and analysis operations
4. Familiar with inspection records and COA audits of raw materials, finished products, and intermediate products, skilled at identifying anomalies.