职位描述
验证经理岗位职责:
提供药品生产验证咨询(厂房/设施/设备/工艺等);
Consulting for Pharmaceutical plant Validation(Premises/facility/equipment/process etc)
负责组织药厂验证活动的计划和实施(包括建造期间的IO/PQ确认活动和生产期间的验证活动)
Responsible for validation consulting planning and execution (including IO/PQ and process validation)
参与验证咨询和服务销售支持活动
Participating validation consulting and service sales support.
负责根据客户产品和工艺编制/审核验证咨询文件、培训和指导客户验证活动实施;
Preparing/Review validation consulting documents; training and directing client implementation.
专业技能及经验要求
JOB KNOWLEDGE SKILLS AND EXPERIENCE
8年以上药厂或制药工程验证或QA工作经验
Over eight years work experience include validation or QA in Pharmaceutical plants or Pharmaceutical Engineering fields
熟悉药品生产验证相关法规和指南(EU, USA, WHO, PIC/S, ISPE and ICH)
Familiar with the relevant regulations/guidelines of the pharmaceutical manufacturing practice and validation of EU, USA, WHO, PIC/S, ISPE and ICH.
本科以上学历
At least bachelor degree majoring in Pharmaceutical or Engineering.
英语熟练
Good English Skills
能经常出差
Business trip in China is preferred.