杭州招聘

职位描述：
1.0 目的PURPOSE
1.1 明确GMP培训岗位的职责及资质要求
To clearly define the job description and qualification of Validation Team leader
2.0 职责DUTY
2.1 汇报范围Scope of the Reporting Structure
2.2.1 直接上级：高级主任
Direct supervisor: Director, Validation

2.2.2 所属下级：工艺验证工程师、清洁验证工程师、生产设备验证工程师、公用系统验证工程师、CTUs 设备验证工程师、计算机系统验证工程师、实验室设备验证工程师
Direct subordinate: Process Validation Engineer, Cleaning Validation Engineer, MFG Equipment Validation Engineer, Facility & Utilities Validation Engineer, CTUs Validation Engineer, CSV Engineer, Lab Instrument Validation Engineer.

2.3 工作职责Job Responsibility
2.3.1 管理从需求分析或产品开发到商业生产阶段的验证及确认的活动和生命周期，包括各类的设备、产房、设施、计算机系统，或者清洁、分析方法及工艺。
Manage validation & qualification activities and system lifecycle from requirements analysis or product development to commercialization manufacturing, covering various equipment/facilities/utilities/computer systems or cleaning/analytical methods/processes.

2.3.2 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；
Write company’s Validation Master Plan, Annual Re-validation Plan and Annual Validation Summary Report;

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

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

2.3.5 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. Responsible for executions of Computerized System Validation, Method Validation, Shipping Validation , Cleaning Validation and Process Validation;

2.3.6 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; Review and approve the validation internal deviation.

2.3.7 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。
Responsible for construction, maintenance and management of Validation Group; Tracking the executions of plan in validation group.
3.0 人员资质 PERSONNEL QUALIFICATION
3.1 本科及以上学历，生物学、药学等相关专业；
Bachelor degree or above，major in biological or pharmaceutical engineering；

3.2 至少7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 7 years of working experience in Validation; Familiar with the qualification of Facility, Equipment/instrument and Utility; Familiar with Computerized System Validation, Method Validation, Shipping Validation, Cleaning Validation and Process Validation;

3.3 至少4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 4 years of working experience in Validation Management; Familiar with relevant regulations and guidelines of validation;

3.4 良好的英语听说读写能力，熟练的使用计算机办公软件；
Proficient in spoken and written English. Good skills in computer software;

3.5 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 skills; 举报 分享

上海药明生物技术有限公司诚聘