岗位职责：
1.负责验证项目FL的团队建设，代表验证团队对接内外部客户，优化项目管理流程和验证评估策略。
Responsible for team building of production project FL in validation team, to connect and communication with clients both internally and externally. Be responsible for optimizing project management process and validation evaluation strategies.
2.负责新建厂房的调试&验证工作。
Responsible for C&Q of new facilities.
3.负责CTU和运输验证工作。
Responsible for CTU qualification and shipping validation.
4.负责厂房设施和公用系统的验证工作
Responsible for the qualification of facilities and utilities.
5.负责对变更相关进行验证技术评估。
Responsible for technical assessments of changes.
6.负责官方和客户的审计，包括审计前的准备工作和审计后的回复。
Responsible for official and client audits, including pre-audit preparation and post-audit responses.
7.完成领导安排的其他工作，定期向上级领导汇报工作进展。
Complete other tasks assigned by the leader, and regularly reporting the progress to the superiors.

任职要求：
1.本科以上学历，生物学和药学相关学科。
Bachelor Degree above，major in biology or pharmacy.
2.8年以上制药或者验证工作经验。
At least 8 years of working experience in pharmaceutical or validation.
3.熟悉NMPA、FDA、EMA以及ISPE、PDA等法规指南对于验证的要求。
Be familiar with the requirements of validation according to the regulations and guides of NMPA, FDA, EMA, ISPE, and PDA etc.
4.相当熟练的计算机使用技能。
Quite skillful in using computer software.
5.具备较丰富的项目管理经验
Experienced in project management
6.较强的英语听说读写能力。
Fairly strong in spoken and written English language.