杭州招聘

职位描述：
岗位职责：
1.制定公司的验证主计划、年度再验证计划以及年度验证总结报告；
Draft company’s Validation Master Plan , Annual Re-validation Plan and Annual Validation Summary Report;

2.制定验证的管理流程以及相关的SOP；
Establish and maintain validation procedure and relevant SOP ;

3.审核URS、验证方案和报告；
Review URS ,Validation Protocol and Report;

4.主导验证活动的执行，确保厂房设施公用系统、设备和计算机化系统的处于验证状态；负责计算机系统验证、分析方法验证、运输验证、清洁验证和工艺验证的实施；
Lead the validation execution. Ensure the facility & utility, equipment and computerized system are in validation status. Be responsible for executions of Computerized System Validation, Method Validation ,Shipping Validation , Cleaning Validation and Process Validation;

5.从验证角度审核偏差及变更；批准验证内部偏差。
Review deviation and change from validation perspective; approve the validation internal deviation.

6.负责验证团队的组建、维护和管理，跟踪验证组内计划的实施。
Be responsible for construction, maintenance and management of Validation Group; Tracking the executions of plan in validation group.

岗位要求：
1.本科及以上学历，生物学、药学等相关专业；
Bachelor degree or above，major in biology or pharmacy；

2.至少5年以上验证工作经验；熟悉厂房设施、设备、公用系统的确认，熟悉计算机系统验证、分析方法验证、运输验证、清洁验证和工艺验证；
At least 5 years of working experience in Validation ;Be familiar with the qualification of Facility, Equipment/instrument and Utility ;and be familiar with Computerized System Validation, Method Validation, Shipping Validation ,Cleaning Validation and Process Validation;

3.至少2年的验证管理工作经验；熟悉相关法规、指南对于验证的要求；
At least 2years of working experience in Validation Management ; Be familiar with relevant regulation and guide of validation ;

4.良好的英语听说读写能力，熟练的使用计算机办公软件；
Well verse in spoken and written English language, Skillful in using computer software;

5.有较强的分析问题能力及良好的沟通技巧、工作认真、细致，具有良好的团队合作精神。
Excellent communication, problem-solving , and organization skills, Attentive, careful and meticulous, with strong team-work ability; 举报 分享

上海药明生物技术有限公司诚聘