?起草公司验证主计划;
?起草公司设施,设备的相关验证文件;
?按照主计划实施CTU设备,设施的相关验证工作;
?处理验证过程中的偏差和变更处理;
?负责公司计算机系统的验证工作;
?验证完成后的数据整理归档和统计;
?负责公司验证管理工作,改进验证体系;
?处理审计或其他相关整改措施;
?相关SOP撰写及修订,并落实培训;
?参与公司GMP体系的持续改善;
?领导安排的与岗位相关的其它工作。
?Drafting company VMP;
?Drafting company validation documents of the facilities and equipment;
?Executing CTU equipment and facilities validation work according to VMP;
?Handling deviations and changes in the validation process;
?Responsible for the company CSV;
?Data collection and statistics after validation;
?Responsible for Validation management and improvement of Validation system
?Handling audit or other relevant corrective action;
?Drafting SOP related Validation,and implement the trainning;
?Participate in the continuous improvement of GMP system;
?Other work related to the position arranged by Boss.