1. 负责公司产品与工艺相关验证体系的建立、更新、实施与维护，包括：工艺验证、清洁验证、运输验证等, 公司各生产基地验证活动按最新法规要求，公司规定的程序、计划及方案进行；
Responsible for the establishment,update, implementation and maintenance of the company's product and process-related verification system.Including Process validation,Cleaning validation,Transport validation etc,The verification activities of each production base of the company shall be carried out according to the latest regulations, procedures, plans and schemes stipulated by the company；
2. 按公司验证方针、政策执行验证；评估、制定验证策略；根据验证计划起草、组织工艺验证、清洁验证及运输验证等验证活动，组织相关培训，汇总分析验证数据并总结验证报告，保证验证过程中的行为与记录符合GMP要求；
Perform validation according to the company's validation policies and policies,Evaluate and develop validation strategy; According to the validation plan drafting,organizing process validation, cleaning validation,transportation validation and other verification activities ,organizing the relevant training, summarizing and analyzing the validation data and summarizing the validation report,to ensur that the behaviors and records in the validation process meet the GMP requirements
3. 协调、组织持续工艺确认的实施，对公司商业化期间的工艺状况持续关注，按持续工艺确认计划汇总分析批生产数据，跟技术支持团队合作优化工艺控制策略；
Coordinate and organize the implementation of continued process qualification,continuous attention to th process status during the commercialization of the company, collect and analyze the batch production data according to the continued process qualification plan, and cooperate with the technical support team to optimize the process control strategy.
4. 参与验证相关的偏差调查并提供有效的纠正措施和预防措施；
Participate in verification idation related deviation survey and provide effective corrective and preventive action；
5. 协助工艺验证相关文件审核，包括方案、报告、风险评估和标准操作规程等；
Assist Process validation related document audit,Including Progrem,Report, Risk assessment and Standard operating procedures,etc；
6. NDA资料撰写、审核、验证有关的项目管理；
NDA data writing, examine and verify, Verification related project management.
7. 完成上级交办的其他工作。
Finish other tasks assigned by the superior.

任职资格
1. 教育要求：本科以上学历，主修生物科学/生物技术/制药学/化学工程或相关学科。
Education requirmengts,College degree, Major in bioscience/biotechnology/pharmacy/chemical engineering or related disciplines.
2. 工作经验要求：至少1年制药公司的工作经历，有验证、QA工作经历及生产背景为佳。
Work experience requirmengts, at least 1 years working experience in pharmaceutical company, verification, Quality Assurance experience and production background is preferred.
3. 岗位技能要求：熟悉国内外的法规和指导原则，有生物技术及其衍生物的相关知识并且熟悉现行GMP；有问题处理的技能，尤其在验证或确认过程中出现的偏差、变更方面；有Office软件和AutoCAD应用能力的为佳。
Job skills requirmengts, familiar with domestic and foreign regulations and guidelines, knowledge of biotechnology and its derivatives,and good knowledge of current GMP,Problem solving skills, especially in the validation or validation process deviations,changes;Familiar with Office software and AutoCAD is preferred.
4. 品性要求：
Quality requirements
1） 工作积极进取，责任心强；
Positive work and strong sense of responsibility；
2） 很强的自我约束力，独立工作并能承受一定的工作压力；
Strong self-discipline, working independently and wisthstand working pressure；
3） 高度的工作热情，良好的团队合作精神；
High work enthusiasm and good team spirit；
4） 良好的沟通能力，有耐心；
Good communication skills and patience；
5） 为人正直严谨。
Be upright and rigorous.