验证项目管理FL（江苏-无锡市新吴区）
岗位职责：
1、 项目统筹管理：负责与国内外客户定期开展项目会，解答客户关于验证策略相关疑问，识别项目所需验证内容，制定相关验证计划，定期汇报项目状态与关键决策，推动验证项目按期完成。
Project coordination and management: Responsible for conducting regular project meetings with domestic and international clients, answering client questions related to validation strategy, identifying the validation activities required for the project, developing the corresponding validation plans, regularly reporting project status and key decisions, and driving validation projects to completion on schedule.
2、跨部门协调与沟通：作为项目负责人协调生产、QA、工艺、采购等内外部干系人，统筹多个验证项目（设备、工艺、洁净室、公用工程、计算机化系统等）的资源、进度与质量，确保验证活动符合GMP及相关法规要求，并推动流程标准化与持续改进。
Cross-functional coordination and communication: As the project lead, coordinate internal and external stakeholders such as Production, QA, Process and Procurement; oversee the resources, schedule and quality of multiple validation projects (equipment, processes, cleanrooms, utilities, computerized systems, etc.); ensure validation activities comply with GMP and relevant regulatory requirements; and promote process standardization and continuous improvement.
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、3年以上制药企业验证，QA或者生产工作经验。
At least 3 years of working experience of validation, QA, or manufacturing in pharmaceutical industry.
3、具备较强的英文沟通能力，
Strong communication skills in English
4、具备较强的学习能力和沟通能力
Strong abilities of learning and communication
5、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.
6、相当熟练的计算机使用技能。
Quite skillful in using computer software.
7、具备一定的项目管理经验
Experienced in project management
8、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.
